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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 is a Phase 1 study that was terminated before completion, run by Servier Bio-Innovation. The registered enrollment target is 13 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06563804
The ClinicalTrials.gov registry entry for NCT06563804 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT06563804 reports 0 study locations.
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.
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