Trials / Terminated
TerminatedNCT06563804
A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML
Phase 1/2 Clinical Trial of S227928, an Anti-CD74 Antibody-Drug Conjugate Targeting MCL-1, as a Single Agent and in Combination With Venetoclax in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Servier Bio-Innovation LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
- Myelodysplastic Syndrome (MDS)/AML
- Chronic Myelomonocytic Leukemia (CMML)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S227928 | For administration via intravenous (IV) infusion |
| DRUG | Venetoclax | For oral administration |
Timeline
- Start date
- 2025-02-25
- Primary completion
- 2025-10-09
- Completion
- 2025-10-09
- First posted
- 2024-08-21
- Last updated
- 2026-03-30
Locations
16 sites across 6 countries: United States, Australia, Finland, France, Germany, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06563804. Inclusion in this directory is not an endorsement.