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NCT06563804 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML
A Phase 1 study, sponsored by Servier Bio-Innovation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT06563804: Clinical Trial Phase 1 study, sponsored by Servier Bio-Innovation.
NCT06563804 is a Phase 1 study that was terminated before completion, run by Servier Bio-Innovation. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06563804, a Phase 1 study, was terminated before completion, sponsored by Servier Bio-Innovation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this combination. The study will begin as a Phase 1 Dose Escalation study to determine the RP2D and then will transition to a Phase 2 Dose Expansion study to assess the efficacy of the selected RP2D. During the treatment period participants will have study visits every two weeks, with additional visits occurring during the first and second cycle. Approximately 30 days after treatment has ended, an end-of-treatment visit will occur and then participants will be followed for survival every 12 weeks for the next 6 months. Study visits may include a bone marrow aspirate and/or biopsy, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.
Interventions
- DRUG Venetoclax
- DRUG S227928
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2025-10-09 |
| Phase | Phase 1 |
Why NCT06563804 stopped before completion
NCT06563804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT06563804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06563804 about?
NCT06563804 is a clinical study titled "A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML". The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this combination. The study will begin as a Phase 1 Dose Escalation study to determi...
What is the current status of trial NCT06563804?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2025-02-25. Estimated completion is 2025-10-09.
What interventions are being tested in trial NCT06563804?
The interventions under investigation include: Venetoclax (DRUG), S227928 (DRUG).
Who is sponsoring clinical trial NCT06563804?
This trial is sponsored by Servier Bio-Innovation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06563804's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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