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

Sponsor
Suzhou Transcenta Therapeutics Co., Ltd.
Study ID
NCT04495296
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TST001 — DRUG
    TST001 will be administered by specified doses on specified day
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered by specified doses on specified day
  • Capecitabine — DRUG
    Capecitabine will be administered by specified doses on specified day
  • Paclitaxel — DRUG
    Paclitaxel will be administered by specified doses on specified day
  • Gemcitabine — DRUG
    Gemcitabine will be administered by specified doses on specified day
  • Cisplatin — DRUG
    Cisplatin will be administered by specified doses on specified days Oxaliplatin will be administered by specified doses on specified day Drug: Capecitabine Capecitabine will be administered by specified doses on specified day
  • Nivolumab — DRUG
    Nivolumab will be administered by specified doses on specified day

Study Details

This is an open-label, multi-center, Phase I trial of TST001. Subjects with locally advanced or metastatic solid tumors will be enrolled. The study will consist of two parts: Part A is dose escalation and dose expansion phase for mono-therapy, and Part B is dose escalation and dose expansion phase for combination therapy in gastric, gastroesophageal junction(G/GEJ) and biliary tract cancer, etc.

Key Dates

Start date
Aug 13, 2020
Status verified
Dec 2025
Primary completion
Jun 25, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: dose escalation Q2W
    Dosed every 2 weeks IV with TST001, multiple dose levels will be tested.
  • Experimental: dose escalation Q3W
    Dosed every 3 weeks IV with TST001, multiple dose levels will be tested.
  • Experimental: Cohort A
    Participants with gastric or gastroesophageal junction cancers and CLDN18.2 expression
  • Experimental: Cohort B
    Participants with ductal adenocarcinoma of pancreas and CLDN18.2 expression and CLDN18.2 expression
  • Experimental: Cohort E
    Participants with advanced or metastatic solid tumors other than G/GEJ adenocarcinoma and CLDN18.2 expression
  • Experimental: Cohort C
    Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
  • Experimental: Cohort D
    Participants with locally advanced or metastatic G/GEJ adenocarcinoma
  • Experimental: Cohort F
    Participants with locally advanced or metastatic biliary tract cancer
  • Experimental: Cohort G
    Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
  • Experimental: Cohort H (TST001 plus nivolumab)
    Participants with locally advanced or metastatic G/GEJ adenocarcinoma

Primary Outcome Measure

Participant Safety as characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0). [ Time Frame: up to 30 days following last dose. ]

Central Contacts

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