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Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 27, 2024 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 30, 2024 to Oct 30, 2025 Completion date: Apr 30, 2025 to Feb 28, 2026 · Site details revised at 1 of 3 sitesv5 Show 2 more changesShow less
    • Completion date: Apr 30, 2025 to Feb 28, 2026
    • Site details revised at 1 of 3 sites
  2. Site details revised at 1 of 3 sitesv4
  3. Enrollment target: 82 to 146 Study sites: 2 to 3 · Eligibility criteria expanded, about 460 words · Study title shortened, about 1 wordv3 Show 3 more changesShow less
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 460 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 25, 2023 to Feb 23, 2023 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 25, 2023 to Feb 23, 2023
    • Site details revised at 2 of 2 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.
Trial Details
NCT Number NCT05690581
Lead Sponsor Beijing InnoCare Pharma Tech Co., Ltd.
Conditions Advanced Solid Tumors and Hematologic Malignancies
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov