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A First-in-Human, Phase 1 Study of TST003 in Subjects With 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 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 2026 to Jun 30, 2027
    • Sponsor changed: Suzhou Transcenta Therapeutics Co., Ltd. to Transcenta Therapeutics (Hangzhou) Co., Ltd.
    • Study completion pushed from Dec 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 36 words
  2. Primary completion date: May 2025 to Jun 2026
    • Study completion date: Aug 2025 to Dec 2026
    v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 76 to confirmed 111
    • Site details revised at 3 of 3 sites
    v5
  4. Eligibility criteria shortened, about 33 words
    • Study description shortened, about 17 words
    v4
  5. Study sites: 1 to 3
    • Eligibility criteria shortened, about 49 words
    • Study description expanded, about 3 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 20, 2023 to Feb 8, 2023
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to test the safety of TST003 in patients with cancer. The main question\[s\] it aims to answer are: * What is the recommended dose patients can safely receive? * How long does this drug remain in the body after administration? * What are the side effects of this drug? * Does your cancer respond to TST003? * Participants on this study will get TST003 intravenously (through a needle into your vein), once every 3 weeks. * You may need to come to the study site 2-4 times to have tests to see if you are eligible to be in the study before you begin to receive the study drug. * After you start the study drug, you will need to return to the site several times after each dose so the physician can take vital signs, draw blood samples, and evaluate you for safety and wellbeing. * Participants will continue taking the drug as long as they are receiving clinical benefit. * At the end of your study participation, additional testing is required.
Trial Details
NCT Number NCT05731271
Lead Sponsor Transcenta Therapeutics (Hangzhou) Co., Ltd.
Conditions
(from sponsor)		 Locally Advanced Solid Tumor, Metastatic Tumor, Colorectal Adenocarcinoma
Related terms Neoplasm Metastasis
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov