OncoMatch/Clinical Trials/NCT06969430
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
Is NCT06969430 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Debio 1562M for acute myeloid leukemia.
Treatment: Debio 1562M — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CD37-targeting agent
Any prior exposure to cluster of differentiation (CD) 37 targeting agents.
Cannot have received: antileukemic therapy
Exception: Hydroxyurea may be given prior to and after trial treatment start for control of leukocytosis.
Treatment with any antileukemic therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agent within 14 days or within 5 half-lives of the investigational treatment prior to first dose of trial treatment, whichever is shorter.
Lab requirements
Kidney function
eGFR ≥60 mL/min (CKD-EPIcr 2021 equation)
Liver function
AST and ALT ≤3 × ULN; serum total bilirubin ≤1.5× ULN (≤3.0× ULN for Gilbert's syndrome or chronic blood transfusions)
Cardiac function
No clinically significant cardiac dysfunction within 6 months before enrollment including NYHA Class III or IV heart failure, uncontrolled angina, myocardial infarction, severe uncontrolled ventricular arrhythmias, QTcF >470 ms
Adequate renal and hepatic function defined as: 1. eGFR ≥60 mL/min (CKD-EPIcr 2021 equation). 2. AST and ALT ≤3 × ULN. 3. Serum total bilirubin ≤1.5× ULN (≤3.0× ULN for Gilbert's syndrome or chronic blood transfusions). Clinically significant cardiac dysfunction within 6 months before enrollment including New York Heart Association Class III or IV heart failure, uncontrolled angina, myocardial infraction, severe uncontrolled ventricular arrhythmias, QTcF >470 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- Moffitt Cancer Center and Research Institute Hospital · Tampa, Florida
- University of Chicago · Chicago, Illinois
- START Midwest · Grand Rapids, Michigan
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify