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Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Sep 13, 2026 → Dec 30, 2027
Primary endpoints added 1 → 3 primary endpoints
See other at-risk trials from Grit Biotechnology

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Sep 13, 2026 to Dec 30, 2027v4 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 18 → 78 participants
    • Start date: Sep 13, 2023 to Nov 1, 2025
    • Study sites: 4 to 2
    • Interventions: GT201 (Drug) to GT201 (Biological), IL-2 (Biological), PD-1 inhibitor (Biological)
    • Eligibility criteria expanded, about 728 words
    • Secondary endpoints: 1 to 9
    • Study title expanded, about 10 words
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Minor Study sites revised (4)v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a multicenter Phase I/II clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors.
Trial Details
NCT Number NCT06144671
Lead Sponsor Grit Biotechnology
Conditions
(from sponsor)
Advanced Solid Tumors
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov