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A Study of IBI363 in Subjects With Advanced Melanoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 4 months later Jun 6, 2025 → Oct 19, 2028
See other at-risk trials from Innovent Biologics (Suzhou) Co. Ltd.

Record History

  1. Notable Primary completion pushed from Jun 6, 2025 to Oct 19, 2028 Enrollment increased: 150 → 180 participants · Completion pushed from Jul 31, 2026 to Oct 19, 2028v7 Show 2 more changesShow less
    • Enrollment increased: 150 → 180 participants
    • Completion pushed from Jul 31, 2026 to Oct 19, 2028
  2. Minor Enrollment target: 120 to 150v6
  3. Minor Study sites: 10 to 12v5
  4. Minor Study sites: 1 to 10v4
  5. Notable Phase: Phase 1/2 to Phase 2 Enrollment target: 20 to 120 · Primary endpoints: 3 to 7 · Secondary endpoints: 6 to 4v3 Show 3 more changesShow less
    • Enrollment target: 20 to 120
    • Primary endpoints: 3 to 7
    • Secondary endpoints: 6 to 4

    See this version in full on ClinicalTrials.gov ↗

  6. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 13, 2023 to Oct 19, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 13, 2023 to Oct 19, 2023
    • Site details revised
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
Trial Details
NCT Number NCT06081920
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Melanoma
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov