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NCT06969430 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Debiopharm International.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
- 7
- Study locations
NCT06969430: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by Debiopharm International.
NCT06969430 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Debiopharm International. The registered enrollment target is 134 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (17% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06969430, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Debiopharm International.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
- 7
- Study locations
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 |
What NCT06969430 shows while recruiting
NCT06969430 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (17% higher).
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.
NCT06969430 lists 7 locations in 7 states (California, Florida, Illinois).
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.
What interventions are being tested in trial NCT06969430?
The interventions under investigation include: Debio 1562M (DRUG).
Who is sponsoring clinical trial NCT06969430?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06969430's enrollment target sits among peer trials
134 60th of 306 higher than 247 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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