A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 68 words
    • Site details revised at 2 of 2 sites
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Eligibility criteria expanded, about 138 words
    • Secondary endpoints: details revised at 3 of 44 entries
    v3
  3. Secondary endpoints: details revised at 1 of 44 entries
    • Study title shortened, about 2 words
    v2
  4. Study First Submitted
  • 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 single-arm, open-label multicenter Phase I/II study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/recurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.
Trial Details
NCT Number NCT06590246
Lead Sponsor Shanghai AbelZeta Ltd.
Conditions
(from sponsor)		 Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov