A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

Summary

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Description

There are two parts in the study. Part I is mono-therapy dose escalation and dose expansion study, and Part II is dose escalation and dose expansion study of combination therapy. Part I: Mono-therapy dose escalation and dose expansion study: Mono-therapy dose escalation regimen: The dose escalation ...

There are two parts in the study. Part I is mono-therapy dose escalation and dose expansion study, and Part II is dose escalation and dose expansion study of combination therapy. Part I: Mono-therapy dose escalation and dose expansion study: Mono-therapy dose escalation regimen: The dose escalation study will be conducted using 3+3 dose escalation method at two dosing regimens, i.e."once every 2 weeks (Q2W)"and"once every 3 weeks (Q3W)". Mono-therapy dose expansion regimen: When the dose level in Q2W group in the mono-therapy dose escalation study is escalated to the MTD/MAD/RP2D, two expansion cohorts will be added at this dose level with about 30 (20-40) subjects with positive CLDN18.2 expression. Group A: TST001 RP2 DG/GEJ adenocarcinoma with positive CLDN18.2 expression 20-40 Group B: TST001 RP2D Non-G/GEJ adenocarcinoma with positive CLDN18.2 expression 20-40 Part II: Dose escalation and dose expansion study of combination medication The dose escalation and dose expansion study will be conducted in the following two cohorts: Group C - first line: TST001+CAPOX Positive CLDN18.2 expression GEJ C 20-40 Group D-second-line +: TST001+paclitaxel Positive CLDN18.2 expression G/GEJ 20-40 The trial will last approximately 3 years from the enrollment to the completion of both Par I and II studies, sample size approximate 165-210 subjects?with assessments including safety labs, ECGs, MUGA scans, PKs and PDs and CT/MRI tumor assessments, based on the Q2W and Q3W dosing schedules.

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