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

17 luglio 2026 aggiornato da: Servier

A Phase 1/2, Open Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination With Other Antileukemic Agents in Participants With Selected Myeloid Malignancies

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.
  • Any anticancer therapy within 2 weeks or 5 half-lives (28 days for biologics). Cytoreduction with hydroxyurea or cytarabine is permitted.
  • Prior use of experimental KRAS/BRAF/MEK/ERK inhibitors (prior FLT3 inhibitors are permitted).
  • Uncontrolled infections (human immunodeficiency virus (HIV)/hepatitis B virus (HBV)/hepatitis C virus (HCV) permitted only if viral load is undetectable/controlled and specific cluster of differentiation 4 (CD4)+ criteria are met).
  • Malabsorption, Crohn's, or chronic vomiting that impacts oral drug absorption.
  • History/risk of retinal vein occlusion (RVO), glaucoma, or hyper-viscosity syndromes.
  • Other active malignancy requiring systemic therapy within 2 years (except non-melanoma skin cancer or localized/cured tumors).
  • Stroke, myocardial infarction (MI), unstable angina, or acute coronary syndrome within 6 months.
  • Congestive heart failure (CHF), clinically significant cardiac arrhythmias according to the investigator's judgement (e.g., ventricular tachycardia), complete left bundle branch block and high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II- and third degree AV block).
  • Fridericia-corrected QT interval (QTcF) > 470 msec or history of Torsades de pointes.
  • Disseminated intravascular coagulation (DIC), significant coagulopathy according to the investigator's judgement, or uncontrolled bleeding.
  • Proton Pump Inhibitors (PPIs) and potassium-competitive acid blockers ≥ 7 days prior to Cycle 1 Day 1.
  • Breast cancer resistance protein (BCRP) sensitive substrate or with a narrow therapeutic index (NTI)
  • All herbal preparations/supplements are prohibited.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Part 1A: Dose Escalation
Droga: S241656
Tablets taken by mouth.
Sperimentale: Part 1B: Optional Drug-Drug Interaction [DDI] Substudy
Droga: S241656
Tablets taken by mouth.
Droga: Posaconazole
Tablets taken by mouth

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1A and 1B) Number of Adverse Events (AEs)
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of Serious Adverse Events (SAEs)
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Severity of AEs
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Severity of SAEs
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of AEs
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of SAEs
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of changes in safety laboratory results
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of changes in physical examination
Lasso di tempo: Through 30 days after the last dose of treatment, up to approximately 4 years
Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose reductions due to AEs
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose interruptions due to AEs
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose delays due to AEs
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of study withdrawals due to AEs
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1B only) Maximum concentration (Cmax) of S241656
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Cmax of metabolite S243796
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Time corresponding to Cmax (Tmax) of S241656
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Tmax of metabolite S243796
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Terminal half-life (t1/2) of S241656
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) t1/2 of metabolite S243796
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Area under the curve (AUC) of S241656
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) AUC of metabolite S243796
Lasso di tempo: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
(Part 1A only) Cmax of S241656
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) Cmax of metabolite S243796
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of S241656
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of metabolite S243796
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of S241656
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of metabolite S243796
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) t1/2 of S241656
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) t1/2 of metabolite S243796
Lasso di tempo: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Complete remission (CR)
Lasso di tempo: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with incomplete hematologic recovery (CRi)
Lasso di tempo: Through study completion, approximately 4 years
In participants with AML or MDS/AML only
Through study completion, approximately 4 years
(Part 1A and 1B) Morphologic leukemia free state (MLFS)
Lasso di tempo: Through study completion, approximately 4 years
In participants with AML or MDS/AML only
Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with partial hematologic recovery (CRh)
Lasso di tempo: Through study completion, approximately 4 years
In participants with AML or MDS/AML only
Through study completion, approximately 4 years
(Part 1A and 1B) Partial response (PR)
Lasso di tempo: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Objective response (OR)
Lasso di tempo: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Composite complete remission (CRc)
Lasso di tempo: Through study completion, approximately 4 years
In participants with AML or MDS/AML only
Through study completion, approximately 4 years
(Part 1A and 1B) Red blood cell (RBC) and platelet transfusion independence for at least 8 weeks
Lasso di tempo: Through end of treatment, up to approximately 4 years
In participants with AML or MDS/AML only
Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of response (DOR)
Lasso di tempo: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Time to response (TTR)
Lasso di tempo: Through study completion, approximately 4 years
In participants with AML or MDS/AML only
Through study completion, approximately 4 years
(Part 1A and 1B) Event free survival (EFS)
Lasso di tempo: Through study completion, approximately 4 years
In participants with AML or MDS/AML only
Through study completion, approximately 4 years
(Part 1A and 1B) Overall survival (OS)
Lasso di tempo: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Marrow response
Lasso di tempo: Through end of treatment, up to approximately 4 years
In participants with CMML only
Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of participants with erythroid-, neutrophil-, platelet or spleen-response
Lasso di tempo: Through end of treatment, up to approximately 4 years
In participants with CMML only
Through end of treatment, up to approximately 4 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Servier

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 settembre 2026

Completamento primario (Stimato)

1 novembre 2027

Completamento dello studio (Stimato)

30 settembre 2030

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • S241656-292
  • 2025-525128-88-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Periodo di condivisione IPD

After Marketing Authorization in EEA or US if the study is used for the approval.

Criteri di accesso alla condivisione IPD

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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