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A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Debiopharm International SA

Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Primary endpoint(s) modified
    • Enrollment increased: 134 → 154 participants
    • Secondary endpoints revised (12)
    v12
  3. Site details revised at 1 of 7 sitesv11
  4. 5 versions Re-verified since Oct 30, 2025, no change to tracked fieldsv6-v10
  5. Site details revised at 2 of 7 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 5 to 7v4
  2. Study sites: 3 to 5v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of May 2025 to May 30, 2025
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of Phase 1 is to characterize the safety and tolerability to identify the recommended dose (RD) of Debio 1562M for further development. The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
Trial Details
NCT Number NCT06969430
Lead Sponsor Debiopharm International SA
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 154 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov