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

17. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

64

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Part 1A: Dose Escalation
Arzneimittel: S241656
Tablets taken by mouth.
Experimental: Part 1B: Optional Drug-Drug Interaction [DDI] Substudy
Arzneimittel: S241656
Tablets taken by mouth.
Arzneimittel: Posaconazole
Tablets taken by mouth

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1A and 1B) Number of Adverse Events (AEs)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Cmax of metabolite S243796
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Time corresponding to Cmax (Tmax) of S241656
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Tmax of metabolite S243796
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Terminal half-life (t1/2) of S241656
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) t1/2 of metabolite S243796
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) Area under the curve (AUC) of S241656
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)
(Part 1B only) AUC of metabolite S243796
Zeitfenster: Through Cycle 1 (28 days)
Through Cycle 1 (28 days)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
(Part 1A only) Cmax of S241656
Zeitfenster: 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
Zeitfenster: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of S241656
Zeitfenster: 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
Zeitfenster: Through end of treatment, up to approximately 4 years
Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of S241656
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with incomplete hematologic recovery (CRi)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Objective response (OR)
Zeitfenster: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Composite complete remission (CRc)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Time to response (TTR)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Through study completion, approximately 4 years
Through study completion, approximately 4 years
(Part 1A and 1B) Marrow response
Zeitfenster: 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
Zeitfenster: Through end of treatment, up to approximately 4 years
In participants with CMML only
Through end of treatment, up to approximately 4 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Servier

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. September 2026

Primärer Abschluss (Geschätzt)

1. November 2027

Studienabschluss (Geschätzt)

30. September 2030

Studienanmeldedaten

Zuerst eingereicht

8. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Juli 2026

Zuerst gepostet (Tatsächlich)

22. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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