Not Yet RecruitingPhase 1/2

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

64 participantsStarted 2026-09-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Investigator-assessed life expectancy of ≥ 3 months. * Able and willing to comply with requirements of the study protocol. * Documented genetic characterization of the disease as per local practice. * Clinical and laboratory thresholds: * Cytoreduction: white blood cell (WBC) \< 25 × 10⁹/L (hydroxyurea/cytarabine/leukapheresis allowed). * Renal: creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault). * Hepatic: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (5 × if leukemic); Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome). * Part 1 Only: Relapsed/Refractory (R/R), pathologically confirmed AML, MDS/AML, or CMML. * Part 1 Only: Must have failed ≥ 1 approved standard therapy and have no other approved standard options. Exclusion Criteria: * Known hypersensitivity to S241656, or Posaconazole (Part 1B). * Pregnant or breastfeeding; positive serum pregnancy test for WOCBP. * Diagnosis of acute promyelocytic leukemia (French-American-British \[FAB\] M3 classification), MPN, mixed/ambiguous lineage, histiocytic/dendritic cell neoplasms, or AML with isolated extramedullary disease (no marrow/blood involvement). * Active Central Nervous System (CNS) disease (by cytologic or radiographic evidence). * Failure to recover to ≤ Grade 1 from previous toxicities (except Grade 2 neuropathy/alopecia). * Major surgery within 4 weeks…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment

Timeframe: Through Cycle 1 (28 days)

(Part 1A and 1B) Number of Adverse Events (AEs)

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Number of Serious Adverse Events (SAEs)

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Severity of AEs

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Severity of SAEs

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Duration of AEs

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Duration of SAEs

Trial details

NCT IDNCT07719348

SponsorServier

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-01

Contact for this trial

Institut de Recherches Internationales Servier (I.R.I.S.)

+33 1 55 72 60 00 scientificinformation@servier.com

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment

Timeframe: Through Cycle 1 (28 days)

(Part 1A and 1B) Number of Adverse Events (AEs)

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Number of Serious Adverse Events (SAEs)

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Severity of AEs

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Severity of SAEs

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Duration of AEs

Timeframe: Through 30 days after the last dose of treatment, up to approximately 4 years

(Part 1A and 1B) Duration of SAEs