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

Part of paid clinical trials in Duarte, California.

Sponsor
Debiopharm International SA
Study ID
NCT06969430
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Debio 1562M — DRUG
    Administered as intravenous (IV) infusion

Study Details

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.

Key Dates

First listed
May 13, 2025
Start date
May 30, 2025
Status verified
Sep 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Dose Escalation): Debio 1562M
    Participants will receive Debio 1562M intravenously in escalating doses, once in every 3 weeks (Q3W) and once in every week (QW), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.
  • Experimental: Phase 1 (Dose Optimization): Debio 1562M
    Participants will be randomised 1:1 to receive 1 of the 2 Debio 1562M dose(s) and/or dosing schedule(s) selected based on the results from the Phase 1-Dose escalation for further investigation.
  • Experimental: Phase 2: Debio 1562M
    Participants will receive RD of Debio 1562M based on the results from Phase 1-Dose optimization.

Primary Outcome Measure

Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Moffitt Cancer Center and Research Institute HospitalTampaFlorida33612-9416-
University of ChicagoChicagoIllinois60637-
START MidwestGrand RapidsMichigan49546-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203-
The Ohio Sate UniversityColumbusOhio43210-
MD Anderson Cancer CenterHoustonTexas77030-

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By research site
City of Hope Comprehensive Cancer Center· Duarte, CAMoffitt Cancer Center and Research Institute Hospital· Tampa, FLUniversity of Chicago· Chicago, ILSTART Midwest· Grand Rapids, MIRoswell Park Comprehensive Cancer Center· Buffalo, NYThe Ohio Sate University· Columbus, OH

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