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Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 12 → 32 participantsv9
  2. Eligibility criteria expanded, about 1,041 words
    • Study description shortened, about 135 words
    • Site contact updated
    • Collaborators expanded, about 10 words
    v8
  3. Primary endpoint revised
    • Eligibility criteria expanded, about 11 words
    • Study description shortened, about 3 words
    • Study title shortened, about 2 words
    v7
  4. Enrollment target: 32 to 12
    • Primary endpoint revised
    • Eligibility criteria shortened, about 8 words
    v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 30, 2024 to May 12, 2024
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jan 19, 2024 to Apr 30, 2024
    • Study sites: 0 to 1
    • Primary and study completion dates: Jan 19, 2027 to Apr 30, 2027
    v4
  2. Primary and study completion dates: Nov 16, 2026 to Jan 19, 2027
    • Start date: Dec 29, 2023 to Jan 19, 2024
    v3
  3. Enrollment target: 20 to 32
    • Eligibility criteria shortened, about 109 words
    • Study description expanded, about 138 words
    • Study title shortened, about 2 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases. The study consists of two phases, a dose-escalation phase and a dose-expansion phase.
Trial Details
NCT Number NCT06190275
Lead Sponsor Grit Biotechnology
Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions
(from sponsor)		 HNSCC
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov