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Report for Clinical Trial NCT02675829

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.

NCT02675829 Solid Tumor Cancers Lung Cancer Bladder Cancer Urinary Tract Cancers
MeSH: Urologic Neoplasms
HPO: Urinary tract neoplasm

1 Interventions

Name: ado-trastuzumab emtansine

Description: Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.

Type: Drug

Bladder and urinary tract cancers, HER2 amplified Lung cancers, HER2 amplified Lung cancers, HER2 mutant Other solid tumor cancers, HER2 amplified


Primary Outcomes

Description: As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.

Measure: best overall response (ORR)

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 5 SNPs

SNPs


1 L755A

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A ---


2 L755S

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S ---


3 S310F

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S --- --- V777L --- --- V659E --- --- S310F ---


4 V659E

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S --- --- V777L --- --- V659E ---


5 V777L

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S --- --- V777L ---



HPO Nodes


HPO:
Urinary tract neoplasm
Genes 194
GPC3 VAMP7 HNF1B KCNQ1OT1 SOX9 TRIM37 GATA4 BRCA2 FH SLC49A4 NTHL1 PIK3CA WT1 SLC25A11 SDHD ALX4 SRY FAN1 CTNNB1 NR5A1 KEAP1 DICER1 WT1 FIBP FN1 FGFR3 HRAS MAP3K1 EP300 AXIN2 PAX6 IFNG TBX18 MDH2 MLH1 POU6F2 ZFPM2 H19-ICR TRIP13 TRIM28 TSC1 PTEN POU6F2 H19 IGF2 BUB1B KCNQ1 FLCN REST KRAS BUB3 DCC WT1 TSC1 MSH2 HNF1B TP53 PTEN MAX DIS3L2 RNF139 DMRT3 BRCA2 BMPR1A BUB1 CDKN1C AAGAB TSC1 FH MLH3 PIK3CA TMEM127 VHL IGF2 FLCN H19 OGG1 SETBP1 SDHA IGF2 ATP7A TFE3 FH LMNA HNF4A DLST H19 PMS1 SDHB PALB2 WWOX GPC3 REST TSC2 TRIP13 AKT1 BUB1B FLCN SDHC NTHL1 MLH1 PMS2 SDHAF2 LMNA EXT2 TSC2 SRC BUB1 APC SDHB MSH6 HDAC4 BAP1 VHL KLLN KRAS RNF43 DIS3L2 DLC1 MSH2 PIK3CA NOD2 SDHC VHL PIK3CA FOXE1 WT1 MITF SDHD RPS20 NSD1 RB1 H19 H19 TRIM28 PTCH1 FGFR3 GPC4 AKT1 WT1 CCND1 TP53 GPC4 COL14A1 VHL WT1 MET TRIP13 AKT1 MSH6 HABP2 CDC73 KCNQ1OT1 H19 NRAS CDKN1B DIS3L2 CDC73 PRCC IGF2 CDKN1B STK11 WT1 EPCAM WT1 NR0B1 KLLN TSC2 SEC23B GPC3 HNF1A KIF1B DICER1 TGFBR2 SEMA4A PIK3CA PIK3CA MINPP1 RET HRAS WT1 GPC3 WRN SDHB BUB1B FERMT1 CEP57 CDC73 GPC4 DICER1 PTPRJ BMPER FLCN PHF21A