A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML

Part of paid clinical trials in Duarte, California.

Sponsor
Servier Bio-Innovation LLC
Study ID
NCT06563804
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Chronic Myelomonocytic Leukemia (CMML)
  • Myelodysplastic Syndrome (MDS)/AML
  • Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S227928 — DRUG
    For administration via intravenous (IV) infusion
  • Venetoclax — DRUG
    For oral administration

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Mar 2026
Primary completion
Oct 9, 2025
Completion
Oct 9, 2025

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation - Arm A
    S227928 as a single agent
  • Experimental: Dose Escalation - Arm B
    S227928 in combination with venetoclax
  • Experimental: Dose Expansion - Cohort 1
    For participants with R/R AML and MDS/AML. S227928 in combination with venetoclax at RP2D
  • Experimental: Dose Expansion - Cohort 2
    For participants with CMML. S227928 in combination with venetoclax at RP2D

Primary Outcome Measure

Dose Escalation: Number and severity of Dose Limiting Toxicities (DLTs) [ Time Frame: Through Cycle 1 (each cycle is 28 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
The University of KansasFairwayKansas66205-
START MidwestGrand RapidsMichigan49546-
Memorial Sloan KetteringNew YorkNew York10065-
Fred Hutch Cancer CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAThe University of Kansas· Fairway, KSSTART Midwest· Grand Rapids, MIMemorial Sloan Kettering· New York, NYFred Hutch Cancer Center· Seattle, WA

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