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A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2027 Completion date: Dec 31, 2025 to Dec 31, 2028v4 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2028
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 10, 2022 to Feb 14, 2023 · Study sites: 0 to 3v2 Show 2 more changesShow less
    • Start date: Dec 10, 2022 to Feb 14, 2023
    • Study sites: 0 to 3
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 1, open-label, multicenter, dose-escalation \& expansion study to evaluate the safety,tolerability and pharmacokinetics (PK) of LP-108, a BCL-2 inhibitor, combined with azacitidine, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of this combination.
Trial Details
NCT Number NCT05641259
Lead Sponsor Guangzhou Lupeng Pharmaceutical Company LTD.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov