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A Trial to Evaluate Safety and Tolerability 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 1 year 1 month later May 30, 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 May 30, 2026 to Jun 30, 2027
    • Sponsor changed: Suzhou Transcenta Therapeutics Co., Ltd. to Transcenta Therapeutics (Hangzhou) Co., Ltd.
    • Study completion pushed from Nov 30, 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 15 words
  2. Primary completion date: May 30, 2025 to May 30, 2026
    • Study completion date: Sep 30, 2025 to Nov 30, 2026
    v10
  3. Primary completion date: Nov 30, 2024 to May 30, 2025
    • Study completion date: Dec 31, 2024 to Sep 30, 2025
    v9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 19 to 18
    • Primary completion date: Jun 30, 2024 to Nov 30, 2024
    v8
  5. 2 versions Re-verified since Dec 11, 2023, no change to tracked fieldsv6-v7
Show 4 earlier versionsHide 4 earlier versions
  1. Phase: Phase 1 to Phase 1/2v5 Show 8 more changesShow less
    • Primary completion date: Dec 31, 2022 to Jun 30, 2024
    • Primary endpoints: 3 to 5
    • Enrollment target: 124 to 150
    • Study sites: 12 to 19
    • Study completion date: Apr 1, 2023 to Dec 31, 2024
    • Interventions: Nivolumab Injection [Opdivo] (Drug), TST001 (Drug) to Albumin-Bound Paclitaxel (Drug), Gemcitabine (Drug), Nivolumab Injection [Opdivo] (Drug), TST001 (Drug), mFOLFOX6 (Drug)
    • Eligibility criteria expanded, about 129 words
    • Study description expanded, about 152 words
  2. Primary endpoints: 2 to 3v4 Show 7 more changesShow less
    • Enrollment target: 114 to 124
    • Study sites: 1 to 12
    • Interventions: TST001 (Drug) to Nivolumab Injection [Opdivo] (Drug), TST001 (Drug)
    • Eligibility criteria shortened, about 279 words
    • Secondary endpoints: 9 to 7
    • Study description shortened, about 9 words
    • Collaborators expanded, about 2 words
  3. Phase: Early Phase 1 to Phase 1v3 Show 4 more changesShow less
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 12 words
    • Site contact updated
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 552 words
    • Study description shortened, about 64 words
  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 Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.
Trial Details
NCT Number NCT04396821
Lead Sponsor Transcenta Therapeutics (Hangzhou) Co., Ltd.
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Advanced Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Pancreatic Cancer
Related terms Pancreatic Neoplasms, Stomach Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov