Trials / Recruiting
RecruitingNCT06969430
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
A Phase 1/2, First-in-human, Multicenter, Open-label Trial Evaluating the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- Sponsor
- Debiopharm International SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Debio 1562M | Administered as intravenous (IV) infusion |
Timeline
- Start date
- 2025-05-30
- Primary completion
- 2031-11-01
- Completion
- 2031-11-01
- First posted
- 2025-05-13
- Last updated
- 2026-03-30
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06969430. Inclusion in this directory is not an endorsement.