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Report for Clinical Trial NCT02981108

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1/2, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10296 in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

This is a Phase 1/2, open-label, multicenter study of HS-10296 with dose escalation, dose expansion and extension cohorts in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent. The study is designed to evaluate safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of once-daily and orally (PO) administered HS-10296. The overall study design is shown in the flow chart below, which consists of 3 phases: dose escalation, dose expansion and extension cohort.

NCT02981108 Nonsmall Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: HS-10296

Type: Drug

Escalation Cohort 1 Escalation Cohort 2 Escalation Cohort 3 Escalation Co Escalation Cohort 4 Escalation Cohort 5 Expansion Cohort 1 Expansion Cohort 2 Expansion Cohort 3 Phase 2 Expansion


Primary Outcomes

Measure: Incidence of Dose Limiting Toxicity (DLT) Phase I Part

Time: 4 weeks

Measure: Overall Response Rate (ORR) Phase II Part

Time: 12 months

Measure: Progression-free survival (Phase I Part)

Time: 12 months

Measure: Overall Response Rate (Phase I Part)

Time: 6 weeks

Measure: Incidence and severity of AEs, changes in laboratory values, vital signs & ECGs

Time: 12 months

Measure: Area under the plasma concentration versus time curve (AUC) of HS-10296

Time: 4 weeks

Measure: Elimination half-life(T1/2) of HS-10241

Time: 4 weeks

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 3 SNPs

SNPs


1 L858R

5. Patients must fulfill one of the following: - Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria (followed by systemic objective progression (RECIST or World Health Organization [WHO]) while on continuous treatment with an EGFR TKI. 6. --- L858R ---


2 L861Q

5. Patients must fulfill one of the following: - Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria (followed by systemic objective progression (RECIST or World Health Organization [WHO]) while on continuous treatment with an EGFR TKI. 6. --- L858R --- --- L861Q ---


3 T790M

Prior to entry, a result from the central analysis of the patient's T790M mutation status must be obtained. --- T790M ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1