A Study to Evaluate S241656 Alone or in Combination in Participants With Selected Myeloid Malignancies

Sponsor
Servier
Study ID
NCT07719348
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • S241656 — DRUG
    Tablets taken by mouth.
  • Posaconazole — DRUG
    Tablets taken by mouth

Study Details

The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of S241656 and to determine the recommended dose for expansion (RDE) of S241656 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), or chronic myelomonocytic leukemia (CMML). Part 1A dose escalation will determine the RDE to be used in a future expansion stage of the trial. An optional Part 1B drug-drug interaction (DDI) substudy will evaluate the effect of posaconazole on the PK of S241656. The study consists of a screening period of up to 21 days, a treatment period consisting of continuous 28-day cycles of treatment, an end-of-treatment visit, a safety follow-up period, and long-term disease and survival follow-up every 3 months. Participants in the optional DDI substudy may continue treatment in the main study following completion of the DDI assessment period. Participants may undergo bone marrow aspirates and/or biopsies, blood tests, electrocardiograms (ECGs), echocardiograms or multigated acquisition (MUGA) scans, physical examinations, ophthalmologic assessments, and disease response questionnaires.

Key Dates

First listed
Jul 22, 2026
Start date
Sep 15, 2026
Status verified
Jul 2026
Primary completion
Nov 1, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Dose Escalation
  • Experimental: Part 1B: Optional Drug-Drug Interaction [DDI] Substudy

Primary Outcome Measure

(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment [ Time Frame: Through Cycle 1 (28 days) ]

Central Contacts

  • Institut de Recherches Internationales Servier (I.R.I.S.)
    +33 1 55 72 60 00
    [email protected]

Find similar trials

Nationwide
Leukemia (other) trialsOncology trialsBlood cancer trials

Related Studies