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

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 ID
NCT06969430
Phase
PHASE1 / PHASE2
Sponsor
Debiopharm International SA
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Debio 1562M
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Tampa, Florida, United States|27.94752,-82.45843
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Buffalo, New York, United States|42.88645,-78.87837

Key Eligibility Criteria

  • For Phase 1-Dose escalation: Relapsed/refractory (R/R) AML (excluding acute promyelocytic leukemia) based on World Health Organization (WHO) Classi…
  • For Phase1-Dose optimization and Phase 2: R/R AML (excluding acute promyelocytic leukemia) based on world health organization (WHO) classification …
  • Eastern Cooperative Oncology Group performance (ECOG PS) status ≤2.
  • Previous treatment-related toxicities must be resolved to ≤Grade 1 (excluding alopecia).

For full eligibility, visit ClinicalTrials.gov.

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