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A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
NCT06969430 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Debio 1562M
Study Locations (7)
California
- City of Hope Comprehensive Cancer Center — Duarte
Florida
- Moffitt Cancer Center and Research Institute Hospital — Tampa
Illinois
- University of Chicago — Chicago
Michigan
- START Midwest — Grand Rapids
New York
- Roswell Park Comprehensive Cancer Center — Buffalo
Ohio
- The Ohio Sate University — Columbus
Texas
- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2031-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06969430
The ClinicalTrials.gov registry entry for NCT06969430 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention — of which Debio 1562M is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06969430 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06969430 about?
NCT06969430 is a clinical study titled "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 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.
What is the current status of trial NCT06969430?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2025-05-30. Estimated completion is 2031-11.
What conditions does trial NCT06969430 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06969430?
The interventions under investigation include: Debio 1562M (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06969430?
This trial is sponsored by Debiopharm International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06969430 being conducted?
This trial has 7 study locations across California, Florida, Illinois, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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