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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 25, 2026 → Jun 30, 2027
See other at-risk trials from Transcenta Therapeutics (Hangzhou) Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 25, 2026 to Jun 30, 2027 Show 6 more changesShow less
    • Sponsor changed: Suzhou Transcenta Therapeutics Co., Ltd. to Transcenta Therapeutics (Hangzhou) Co., Ltd.
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 1, 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised at 40 of 40 sites
  2. Primary completion date: Feb 25, 2025 to Jun 25, 2026
    • Study completion date: May 1, 2025 to Dec 1, 2026
    v9
  3. Primary completion date: Aug 31, 2024 to Feb 25, 2025
    • Study completion date: Nov 1, 2024 to May 1, 2025
    v8
  4. Primary completion date: Dec 31, 2023 to Aug 31, 2024
    • Study completion date: Apr 1, 2024 to Nov 1, 2024
    v7
  5. Phase: Phase 1 to Phase 1/2v6 Show 11 more changesShow less
    • Enrollment target: 210 to 320
    • Primary completion date: Aug 31, 2022 to Dec 31, 2023
    • Primary endpoints: 6 to 7
    • Study sites: 3 to 40
    • Study completion date: Jan 1, 2023 to Apr 1, 2024
    • Interventions: TST001 injection (Biological) to Capecitabine (Drug), Cisplatin (Drug), Gemcitabine (Drug), Nivolumab (Drug), Oxaliplatin (Drug), Paclitaxel (Drug), TST001 (Drug)
    • Eligibility criteria expanded, about 478 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 115 words
    • Collaborators: 31 to 1
    • Study arms: 1 to 10
Show 4 earlier versionsHide 4 earlier versions
  1. Collaborators: 11 to 31v5
  2. Collaborators: 5 to 11v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary endpoints revised (6)
    • Study sites: 2 to 3
    • Start date changed from estimate of Aug 1, 2020 to Aug 13, 2020
    • Collaborators: 2 to 5
  4. Primary endpoints: 4 to 6v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04495296
Lead Sponsor Transcenta Therapeutics (Hangzhou) Co., Ltd.
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Advanced Cancer
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov