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 assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization). The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.

Key Dates

Start date
May 30, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
134 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), 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. Participants will be randomized to receive one of the 2 selected doses from Phase 1 (dose escalation) for further investigation and selection of recommended dose (RD) for Phase 2. Participants will receive Debio 1562M intravenously, once in every 3 weeks (Q3W), 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 2: Debio 1562M
    Participants will receive RD of Debio 1562M based on the results from Phase 1-Dose optimization. Participants will receive Debio 1562M intravenously, once in every 3 weeks (Q3W), 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.

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-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
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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