SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT00337467 (13) NCT00098293 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT01614470 (10) NCT01423812 (10) NCT00358917 (10) NCT04415268 (10) NCT00511381 (10) NCT03911713 (9) NCT02742519 (9) NCT02725567 (9) NCT03045523 (9) NCT00438152 (9) NCT01102972 (9) NCT02971839 (9) NCT00740064 (9) NCT02605954 (9) NCT00379405 (9) NCT01562847 (9) NCT02616783 (9) NCT04272242 (9) NCT02445053 (9) NCT00242840 (9) NCT02724527 (9) NCT04209465 (9) NCT04585737 (8) NCT02082977 (8) NCT00112775 (8) NCT00383318 (8) NCT03659214 (8) NCT03631732 (8) NCT00118898 (8) NCT01888562 (8) NCT02633189 (8) NCT03565692 (8) NCT03843775 (8) NCT01161576 (8) NCT02167165 (8) NCT00344461 (8) NCT04519398 (7) NCT02154490 (7) NCT03232892 (7) NCT00650832 (7) NCT04549025 (7) NCT00440947 (7) NCT02784639 (7) NCT03572140 (6) NCT01237444 (6) NCT00532168 (6) NCT01102569 (6) NCT04424368 (6) NCT01414985 (6) NCT00525733 (6) NCT02308332 (6) NCT01487265 (6) NCT00049933 (5) NCT02389920 (5) NCT03351699 (5) NCT04197934 (5) NCT02272998 (5) NCT00122590 (5) NCT04204330 (5) NCT02450591 (5) NCT01173029 (5) NCT02675829 (5) NCT02858921 (5) NCT01914484 (5) NCT00187733 (5) NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT01282151 (3) NCT03058094 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02282267 (2) NCT02684591 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT00525473 (2) NCT03333343 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00834665 (2) NCT00969137 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT00005541 (2) NCT01242813 (2) NCT02906020 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT03720665 (2) NCT04309019 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT00226551 (2) NCT03239145 (2) NCT04511533 (2) NCT02191891 (2) NCT04586270 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03977194 (2) NCT03991013 (2) NCT02500927 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT01841463 (2) NCT04429542 (2) NCT03865511 (2) NCT01218477 (2) NCT03205267 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT01998295 (2) NCT03586453 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) NCT00953706 (2) NCT02346955 (2) NCT03795688 (2) NCT02011945 (2) NCT00857675 (2) NCT00028262 (2) NCT02355431 (2) NCT02495233 (2) NCT04575415 (2) NCT03468985 (2) NCT00230087 (2) NCT02017600 (2) NCT04146298 (2) 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NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT01074398 (1) NCT04500717 (1) NCT03134131 (1) NCT01004497 (1) NCT02455167 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) NCT00867139 (1) NCT03363139 (1) NCT01936051 (1) NCT02341131 (1) NCT00037076 (1) NCT00582907 (1) NCT02169869 (1) NCT03284684 (1) NCT04204473 (1) NCT01074359 (1) NCT01400191 (1) NCT04530565 (1) NCT03530319 (1) NCT04146402 (1) NCT02658682 (1) NCT04241835 (1) NCT03133234 (1) 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NCT00090688 (1) NCT01717404 (1) NCT03590522 (1) NCT02937727 (1) NCT03899857 (1) NCT04133870 (1) NCT03790397 (1) NCT03024281 (1) NCT03389256 (1) NCT03426371 (1) NCT02926638 (1) NCT04193553 (1) NCT00997334 (1) NCT04544202 (1) NCT04201457 (1) NCT00618631 (1) NCT04455594 (1) NCT03439215 (1) NCT02164916 (1) NCT02000882 (1) NCT01897116 (1) NCT03264794 (1) NCT03810066 (1) NCT00125489 (1) NCT04372498 (1) NCT02788669 (1) NCT00367952 (1) NCT00977756 (1) NCT03387072 (1) NCT01586195 (1) NCT02611492 (1) NCT01220648 (1) NCT01708954 (1) NCT01967940 (1) NCT03758287 (1) NCT02392871 (1) NCT04401059 (1) NCT02869932 (1) NCT00716014 (1) NCT01526928 (1) NCT00930215 (1) NCT03228667 (1) NCT04273581 (1) NCT00980018 (1) NCT04557956 (1) NCT01898039 (1) NCT03883087 (1) NCT04364451 (1) NCT04216524 (1) NCT04204551 (1) NCT03672968 (1) NCT03924050 (1) NCT03983252 (1) NCT01639872 (1) NCT02747277 (1) NCT04116918 (1) NCT00669396 (1) NCT02153398 (1) NCT03543306 (1) NCT01377376 (1) NCT01603446 (1) NCT01534520 (1) 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NCT02422719 (1) NCT02754362 (1) NCT03160105 (1) NCT01159145 (1) NCT02782403 (1) NCT02838420 (1) NCT00794885 (1) NCT04410796 (1) NCT04143607 (1) NCT04358562 (1) NCT04306926 (1) NCT01810965 (1) NCT00433862 (1) NCT00949702 (1) NCT01744171 (1) NCT02314143 (1) NCT02713880 (1) NCT02199613 (1) NCT00687518 (1) NCT02923986 (1) NCT04325698 (1) NCT01014546 (1) NCT04568239 (1) NCT01700582 (1) NCT00672035 (1) NCT03115164 (1) NCT01068327 (1) NCT00464113 (1) NCT01933347 (1) NCT03452592 (1) NCT01120964 (1) NCT02186301 (1) NCT01791309 (1) NCT00644878 (1) NCT02550990 (1) NCT02965378 (1) NCT03842969 (1) NCT03952052 (1) NCT04484142 (1) NCT01396408 (1) NCT01274091 (1) NCT02117336 (1) NCT02412943 (1) NCT04607421 (1) NCT01861223 (1) NCT00089297 (1) NCT00570583 (1) NCT01245556 (1) NCT02292732 (1) NCT03087071 (1) NCT02034110 (1) NCT03716908 (1)

SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02783300

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma

The study drug, GSK3326595, is an inhibitor of protein arginine methyltransferase 5 (PRMT5) that potently inhibits tumor growth in vitro and in vivo in animal models. This first time in human (FTIH), open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and NHL. This is an open-label, repeat-dose, multicenter, three-part study to establish the maximally tolerated dose (MTD)/ recommended phase 2 dose (RP2D) based on safety and tolerability and preliminary clinical efficacy of orally-administered GSK3326595. Part 1 is a dose-escalation phase to identify the MTD/RP2D based on the safety, PK, and PD profiles observed after oral administration of GSK3326595 and to preliminarily identify whether or not there is an effect of fed versus fasted state and of tablet versus capsule formulation on the PK of GSK3326595. This Part will be conducted in adult participants with relapsed and/or refractory solid tumors. It is estimated that up to 66 participants will be enrolled into the dose escalation cohort of the study, including up to 42 participants to identify the MTD and approximately 12 participants in the PK/PD/metabolite/biomarker expansion cohort(s) and approximately 12 participants in the food effect and relative bioavailability sub-study. Disease-specific expansion cohorts (Part 2) are planned to further explore clinical activity of GSK3326595 in participants with selected solid tumors and NHL. It is estimated that up to 316 participants will be enrolled in Part 2. Part 3 will be a dose determination study to evaluate the safety, PK/PD profile, and clinical activity of orally-administered GSK3326595 in combination with intravenous pembrolizumab. Overall, approximately 30 participants will be enrolled in Part 3. The duration of study will depend on recruitment rates and the timing of participant's duration on study (withdrawal rates due to toxicity or progression), with an approximate duration of 6 years.

NCT02783300 Neoplasms
MeSH:Lymphoma Lymphoma, Non-Hodgkin
HPO:Lymphoma Non-Hodgkin lymphoma

2 Interventions

Name: GSK3326595

Description: The capsules will be opaque white 12.5 mg, 10 mg, 25 mg and 100 mg capsules. The tablets will be white to almost white film coated 100 mg tablets with no markings. The capsules and tablets will be administered orally with water (approximately 200 milliliter [mL]) at approximately the same time of day (+/- 4 hours) with no food or antacids for 1 hour before and 2 hours after each dose.
Type: Drug
Group Labels: 16

Part 1a: Dose Escalation Part 1b: Food Effect and Relative Bioavailability Part 2a: Disease-Specific TNBC Part 2b: Disease-Specific MTCC Part 2c: Disease-Specific recurrent GBM Part 2d: Disease-Specific NHL p53 mutant Part 2e: Disease-Specific NHL p53 wildtype Part 2f: Disease-specific ACC (GSK3326595 capsule) Part 2g: Disease-specific ACC (GSK3326595 tablet) Part 2h: Disease specific ER+BC Part 2i: Disease-specific HPV Part 2j: Disease specific p53 wild-type NSCLC Part 3: Dose Determination at 100 mg Part 3: Dose Determination at 200 mg Part 3: Part 3: Dose Determination at 300 mg

Name: Pembrolizumab

Description: The solution will be concentrate solution for infusion at 100 mg/4mL administered intravenously every 3 weeks in combination with GSK3326595.
Type: Drug
Group Labels: 3

Part 3: Dose Determination at 100 mg Part 3: Dose Determination at 200 mg Part 3: Dose Determination at 300 mg


Primary Outcomes

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

Measure: Part 1: Number of participants with any adverse events (AEs)

Time: Up to approximately 2 years

Description: An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement.

Measure: Part 1: Number of participants with serious adverse events (SAEs)

Time: Up to approximately 2 years

Description: Number of participants withdrawn due to AEs will be evaluated.

Measure: Part 1: Number of participants withdrawn due to AEs

Time: Up to approximately 2 years

Description: Number of participants with dose interruptions and with dose reductions will be analyzed.

Measure: Part 1: Number of participants with dose interruptions and with dose reductions

Time: Up to approximately 2 years

Description: Number of participants withdrawn due to AEs will be evaluated.

Measure: Part 3: Number of participants withdrawn due to AEs

Time: Up to approximately 2 years

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

Measure: Part 3: Number of participants with any AEs

Time: Up to approximately 2 years

Description: An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement.

Measure: Part 3: Number of participants with SAEs

Time: Up to approximately 2 years

Description: Number of participants with dose interruptions and with dose reductions will be analyzed.

Measure: Part 3: Number of participants with dose interruptions and with dose reductions

Time: Up to approximately 2 years

Description: An event is considered to be a DLT if the event is attributed (definitely, probably or possibly) to the study treatment during the first 21 days of treatment.

Measure: Part 1: Number of participants with dose limiting toxicity (DLT)

Time: Up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 1: Change from Baseline in Hemoglobin (Hb) (Grams per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 3: Change from Baseline in Hb (Grams per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 1: Change from Baseline in Hematocrit (Proportion of red blood cells in blood)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 3: Change from Baseline in Hematocrit (Proportion of red blood cells in blood)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 1: Change from Baseline in Mean Corpuscle Hemoglobin (MCH) (Picograms)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 3: Change from Baseline in MCH (Picograms)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 1: Change from Baseline in Mean Corpuscle Volume (MCV) (Femtoliters)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 3: Change from Baseline in MCV (Femtoliters)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameters.

Measure: Part 1: Change from Baseline in hematology parameter: red blood cells (RBC) Count and Reticulocytes (Trillion cells per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameters.

Measure: Part 3: Change from Baseline in hematology parameter: RBC Count and Reticulocytes (Trillion cells per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameters.

Measure: Part 1: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, platelet count (Giga cells per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameters.

Measure: Part 3: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, platelet count (Giga cells per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 1: Change from Baseline in Blood urea nitrogen (BUN), Creatinine, Glucose (fasting), Sodium, Potassium, Calcium, Total and direct bilirubin (Micromoles per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 3: Change from Baseline in BUN, Creatinine, Glucose (fasting), Sodium, Potassium, Calcium, Total and direct bilirubin (Micromoles per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 1: Change from Baseline in Aspartate Aminotransferase (AST) Alanine Aminotransferase (ALT), Alkaline phosphatase (International units per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 3: Change from Baseline in AST, ALT, Alkaline phosphatase (International units per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 1: Change from Baseline in total protein and albumin (grams per day)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 3: Change from Baseline in total protein and albumin (grams per day)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 1: Change from Baseline in Serum Lipase, Serum Amylase (Units per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 3: Change from Baseline in Serum Lipase, Serum Amylase (Units per liter)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline temperature will be assessed in a seated or semi-supine position with a completely automated device.

Measure: Part 1: Change from Baseline in temperature (Degrees Celsius)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline temperature will be assessed in a seated or semi-supine position with a completely automated device.

Measure: Part 3: Change from Baseline in temperature (Degrees Celsius)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of specific gravity.

Measure: Part 1: Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of specific gravity.

Measure: Part 3: Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Measure: Part 1: Change from Baseline in Urinalysis Parameters- Urine potential of hydrogen (pH)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Measure: Part 3: Change from Baseline in Urinalysis Parameters- Urine pH

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary glucose.

Measure: Part 1: Change from Baseline in urinalysis parameter: Glucose (Millimole per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary glucose.

Measure: Part 3: Change from Baseline in urinalysis parameter: Glucose (Millimole per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary ketones.

Measure: Part 1: Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary ketones.

Measure: Part 3: Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary occult blood.

Measure: Part 1: Change from Baseline in urinalysis parameter: Occult blood (10^9 cells per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary occult blood.

Measure: Part 3: Change from Baseline in urinalysis parameter: Occult blood (10^9 cells per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary protein.

Measure: Part 1: Change from Baseline in urinalysis parameter: Protein

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary protein.

Measure: Part 3: Change from Baseline in urinalysis parameter: Protein

Time: Baseline and up to approximately 2 years

Description: Change from Baseline pulse rate will be assessed in a seated or semi-supine position.

Measure: Part 1: Change from Baseline in Pulse rate (Beats per minute)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline pulse rate will be assessed in a seated or semi-supine position.

Measure: Part 3: Change from Baseline in Pulse rate (Beats per minute)

Time: Baseline and up to approximately 2 years

Description: 12-lead ECGs will be obtained using an ECG machine that automatically calculates and measures PR, QRS, QT, and QTcF intervals. Twelve lead ECG will be measured in a supine or semi supine position after 10 minutes rest.

Measure: Part 1: Change from Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Interval, QT Interval, Corrected QT interval using the Fridericia formula (QTcF) (Milliseconds)

Time: Baseline and up to approximately 2 years

Description: 12-lead ECGs will be obtained using an ECG machine that automatically calculates and measures PR, QRS, QT, and QTcF intervals. Twelve lead ECG will be measured in a supine or semi supine position after 10 minutes rest.

Measure: Part 3: Change from Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, QTcF (Milliseconds)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline in SBP and DBP will be assessed in a seated or semi-supine position with a completely automated device.

Measure: Part 1: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeter of mercury)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline in SBP and DBP will be assessed in a seated or semi-supine position with a completely automated device.

Measure: Part 3: Change from Baseline in SBP and DBP (Millimeter of mercury)

Time: Baseline and up to approximately 2 years

Description: Respiratory rate measurements will be performed in a seated or semi-supine position after 5 minutes of rest.

Measure: Part 1: Number of participants with clinically significant change in respiratory rate

Time: Up to approximately 2 years

Description: Respiratory rate measurements will be performed in a seated or semi-supine position after 5 minutes of rest.

Measure: Part 3: Number of participants with clinically significant change in respiratory rate

Time: Up to approximately 2 years

Description: Organ-specific evaluations will be done for abnormal values.

Measure: Part 1: Number of participants with clinically significant change in organ-specific parameters

Time: Up to approximately 2 years

Description: ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Measure: Part 2: Solid tumor cohorts (non-GBM): Overall response rate (ORR) of participants

Time: Up to approximately 2 years

Description: ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.

Measure: Part 2: NHL cohort(s): ORR of participants

Time: Up to approximately 2 years

Description: PFS is defined as the percentage of participants free from radiographic progression per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, for six months after starting GSK3326595.

Measure: Part 2: GMB cohort: Progression free survival (PFS) rate of participants

Time: Up to approximately 2 years

Description: Organ-specific evaluations will be done for abnormal values.

Measure: Part 3: Number of participants with clinically significant change in organ-specific parameters

Time: Up to approximately 2 years

Description: A complete physical examination will include, assessments of the head, eyes, ears, nose, throat, Skin, thyroid, Cardiovascular, Respiratory, Gastrointestinal, Neurological systems, lymph nodes and extremities. Brief physical examination will include, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen.

Measure: Part 1: Number of participants with abnormality in physical examinations

Time: Up to approximately 2 years

Description: A complete physical examination will include, assessments of the head, eyes, ears, nose, throat, Skin, thyroid, Cardiovascular, Respiratory, Gastrointestinal, Neurological systems, lymph nodes and extremities. Brief physical examination will include, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen.

Measure: Part 3: Number of participants with abnormality in physical examinations

Time: Up to approximately 2 years

Secondary Outcomes

Description: Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition.

Measure: Part 1:Change from Baseline in symmetrical arginine dimethylation (SDMA) as a PD measure

Time: Baseline and up to approximately 2 years

Description: Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition.

Measure: Part 2:Change from Baseline in SDMA as a PD measure

Time: Baseline and up to approximately 2 years

Description: Evaluation of change from baseline in SDMA, a PD biomarker of PRMT5 inhibition.

Measure: Part 3:Change from Baseline in SDMA as a PD measure

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at given time points to study the PK profile of GSK3326595 given as a single dose.

Measure: Part 1: Maximum observed plasma concentration (Cmax) in plasma following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: Cmax in plasma following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: AUC (0-inf) following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood samples will be collected at given time points to study the PK profile of GSK3326595 given as a single dose.

Measure: Part 1: AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) following single-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: AUC(0-t) following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: AUC over the dosing interval tau (AUC[0-tau]) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: AUC(0-tau) following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: Terminal phase half-life (t½) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: t½ following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: Oral clearance (CL/F) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: CL/F following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: Accumulation ratio (AR) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: AR following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: Time invariance (TI) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: TI following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 1: Time to Cmax (tmax) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 1: tmax following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: ORR is defined as the percentage of participants achieving a confirmed CR or PR based on RECIST 1.1 criteria

Measure: Part 1: ORR of participants

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: AUC(0-inf) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: AUC(0-t) following single-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: AUC(0-t) following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: AUC(0-tau) following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: AUC(0-tau) following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: AUC[0-inf] following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: tmax following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: tmax following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: t½ following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: t½ following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: CL/F following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: CL/F following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: AR following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: AR following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: Cmax in plasma following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: Cmax in plasma following repeat-dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in single dose.

Measure: Part 3: TI following single dose administration of GSK3326595

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given in repeat dose.

Measure: Part 3: TI following repeat dose administration of GSK3326595

Time: Up to approximately 2 years

Description: ORR is defined as the percentage of participants achieving a confirmed CR or PR based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and based on independent central review (ICR) in ACC cohort administered with tablet formulation.

Measure: Part 3: ORR of participants

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose.

Measure: Part 1: Cmax following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: Tmax following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: t½ following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AUC (0-t) following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AUC (0-inf) following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AUC (0-tau) following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: CL/F following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: TI following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AR following single-dose administration of GSK3326595 tablets in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: Cmax following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: Tmax following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: t½ following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Tumor biopsies will be performed to obtain p53 gene data.

Measure: Part 2: Relationship between p53 mutational status and ORR in participants with NHL

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AUC (0-t) following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AUC (0-inf) following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AUC (0-tau) following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: CL/F following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AR following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: TI following single-dose administration of GSK3326595 tablets in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: Cmax following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: Tmax following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AUC (0-inf) following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AUC (0-t) following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AUC (0-tau) following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: CL/F following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: TI following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: AR following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fasted condition.

Measure: Part 1: t½ following single-dose administration of GSK3326595 capsules in fasted condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: Cmax following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: Tmax following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AUC (0-inf) following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AUC (0-t) following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AUC (0-tau) following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: CL/F following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: TI following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: AR following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595 given as a single dose in fed condition.

Measure: Part 1: t½ following single-dose administration of GSK3326595 capsules in fed condition

Time: Up to approximately 2 years

Description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Measure: Part 2: Number of participants with any AEs

Time: Up to approximately 2 years

Description: Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

Measure: Part 2: Number of participants with SAEs

Time: Up to approximately 2 years

Description: Number of participants withdrawn due to AEs will be evaluated.

Measure: Part 2: Number of participants withdrawn due to AEs

Time: Up to approximately 2 years

Description: Number of participants with dose interruptions and with dose reductions will be analyzed.

Measure: Part 2: Number of participants with dose interruptions and with dose reductions

Time: Up to approximately 2 years

Description: PFS defined as time from first dose until radiographic progression per standard criteria, or death due to any cause, whichever is earlier.

Measure: Part 2: PFS of participants

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595.

Measure: Part 2: AUC following administration of GSK3326595

Time: Up to approximately 2 years

Description: ORR is defined as CR + PR based on Response Assessment in Neuro-Oncology (RANO) Working Group criteria.

Measure: Part 2: ORR of participants present in GBM cohort

Time: Up to approximately 2 years

Description: Blood sample will be collected at given time points to study the PK profile of GSK3326595.

Measure: Part 2: Cmax, dose concentration following administration of GSK3326595

Time: Up to approximately 2 years

Description: DOR is defined as time from first evidence of response (CR or PR per Immune Response Evaluation Criteria in Solid Tumors [iRECIST 1.1]) to earlier date of disease progression or death due to any cause.

Measure: Part 2: Duration of Response (DOR) for ACC cohort

Time: Up to approximately 2 years

Description: ORR is defined as the percentage of participants achieving a confirmed CR or PR based on RECIST 1.1 criteria.

Measure: Part 2: ORR of participants for ACC cohort

Time: Up to approximately 2 years

Description: OS is defined as time from first dose until death from any cause in ACC participants who are systemic-treatment naïve.

Measure: Part 2: Overall survival (OS) of participants for ACC cohort

Time: Up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 2: Change from Baseline in Hb (Grams per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 2: Change from Baseline in Hematocrit (Proportion of red blood cells in blood)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 2: Change from Baseline in MCH (Picograms)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameter.

Measure: Part 2: Change from Baseline in MCV (Femtoliters)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameters.

Measure: Part 2: Change from Baseline in hematology parameter: RBC Count and Reticulocytes (Trillion cells per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of hematology parameters.

Measure: Part 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, platelet count (Giga cells per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 2: Change from Baseline in BUN, Creatinine, Glucose (fasting), Sodium, Potassium, Calcium, Total and direct bilirubin (Micromoles per liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 2: Change from Baseline in AST, ALT, Alkaline phosphatase (International units per Liter)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 2: Change from Baseline in total protein and albumin (grams per day)

Time: Baseline and up to approximately 2 years

Description: Blood samples will be collected at indicated time points for analysis of chemistry parameters.

Measure: Part 2: Change from Baseline in Serum Lipase, Serum Amylase (Units per liter)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline temperature will be assessed in a seated or semi-supine position with a completely automated device.

Measure: Part 2: Change from Baseline in temperature (Degrees Celsius)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of specific gravity.

Measure: Part 2: Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Measure: Part 2: Change from Baseline in Urinalysis Parameters- Urine pH

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary glucose.

Measure: Part 2: Change from Baseline in urinalysis parameter: Glucose (Millimole per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary ketones.

Measure: Part 2: Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary occult blood.

Measure: Part 2: Change from Baseline in urinalysis parameter: Occult blood (10^9 cells per liter)

Time: Baseline and up to approximately 2 years

Description: Urine samples will be collected at indicated time points for the assessment of urinary protein.

Measure: Part 2: Change from Baseline in urinalysis parameter: Protein

Time: Baseline and up to approximately 2 years

Description: Change from Baseline pulse rate will be assessed in a semi-supine position.

Measure: Part 2: Change from Baseline in Pulse rate (Beats per minute)

Time: Baseline and up to approximately 2 years

Description: Respiratory rate measurements will be performed in a seated or semi-supine position after 5 minutes of rest.

Measure: Part 2: Number of participants with clinically significant change in respiratory rate

Time: Up to approximately 2 years

Description: Temperature measurements will be performed in a seated or semi-supine position after 5 minutes of rest.

Measure: Part 2: Number of participants with clinically significant change in temperature

Time: Up to approximately 2 years

Description: 12-lead ECGs will be obtained using an ECG machine that automatically calculates and measures PR, QRS, QT, and QTcF intervals. Twelve lead ECG will be measured in a supine or semi supine position after 10 minutes rest.

Measure: Part 2: Change from Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, QTcF (Milliseconds)

Time: Baseline and up to approximately 2 years

Description: Change from Baseline in SBP and DBP will be assessed in a semi-supine position with a completely automated device.

Measure: Part 2: Change from Baseline in SBP and DBP (Millimeter of mercury)

Time: Baseline and up to approximately 2 years

Description: A complete physical examination will include, assessments of the head, eyes, ears, nose, throat, Skin, thyroid, Cardiovascular, Respiratory, Gastrointestinal, Neurological systems, lymph nodes and extremities. Brief physical examination will include, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen.

Measure: Part 2: Number of participants with abnormality in physical examinations

Time: Up to approximately 2 years

Description: Organ-specific evaluations will be done for abnormal values.

Measure: Part 2: Number of participants with clinically significant change in organ-specific parameters

Time: Up to approximately 2 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Tumors with actionable mutations (e.g., BRAF V600E gene mutation in melanoma; Epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in NSCLC) must have received prior therapy with targeted agents prior to enrollment. --- V600E ---



HPO Nodes


HPO: