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

17. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Institut de Recherches Internationales Servier (I.R.I.S.)
Telefonnummer: +33 1 55 72 60 00
E-mail: scientificinformation@servier.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Sekventiel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Part 1A: Dose Escalation	Medicin: S241656 Tablets taken by mouth.
Eksperimentel: Part 1B: Optional Drug-Drug Interaction [DDI] Substudy	Medicin: S241656 Tablets taken by mouth. Medicin: Posaconazole Tablets taken by mouth

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Servier

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

30. september 2030

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

STUDY_PROTOCOL
SAP
ICF
CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kontinuerlig infusionskemoterapi (CI-CLAM) til behandling af recidiverende eller refraktær akut myeloid leukæmi eller andre højgradige myeloide neoplasmer

Tilbagevendende akut myeloid leukæmi | Refraktær akut myeloid leukæmi | Myeloid neoplasma

Forenede Stater
Xuzhou Medical University

Rekruttering

Administration af anti Tim-3/CD123 CAR-T celleterapi ved recidiverende og refraktær akut myeloid leukæmi (rr/AML)

Akut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktær

Kina
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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SKLB1028, Daunorubicin og Cytarabin til behandling af patienter med nyligt diagnosticeret akut myeloid leukæmi (AML)

Nydiagnosticeret akut myeloid leukæmi (AML)

Kina
Washington University School of Medicine

Trukket tilbage

Cytokin-inducerede hukommelseslignende NK-celler i kombination med kemoterapi i pædiatriske patenter med refraktær eller recidiverende AML

Refraktær akut myeloid leukæmi | Recidiverende akut myeloid leukæmi

Forenede Stater
C. Babis Andreadis
Gateway for Cancer Research; AVEO Pharmaceuticals, Inc.

Afsluttet

Ficlatuzumab med højdosis cytarabin i recidiverende og refraktær AML

Akut myeloid leukæmi | Refraktær akut myeloid leukæmi | Recidiverende akut myeloid leukæmi

Forenede Stater
Children's Oncology Group
National Cancer Institute (NCI)

Afsluttet

Udvikling og behandling af en musemodel for akut myeloid leukæmi ved hjælp af vævsprøver fra yngre patienter med akut myeloid leukæmi

Akut myeloid leukæmi i barndommen/andre myeloid malignitet

Forenede Stater
University Hospital Tuebingen

Ikke rekrutterer endnu

Multipeptidvaccination adjuveret med XS15 hos patienter med akut myeloid leukæmi (AML-VAC-XS15)

Akut myeloid leukæmi, voksen
Shanghai Jiao Tong University School of Medicine

Rekruttering

Aza-Ven efterfulgt af reduceret toksicitetskonditioneringsregime (MBF) som bjærgningsterapi for refraktær AML.

Refraktær akut myeloid leukæmi

Kina
Hospices Civils de Lyon

Rekruttering

Farmakokinetiske variationer af posaconazol (PCZ) og dets glukuronidmetabolit under induktions- og konsolideringsbehandlinger hos patienter med akut myeloid leukæmi (AML): en kovariat analyse med tabletternes formulering og evaluering af den potentielle risiko for hepatotoksicitet (Posa-Pk)

Leukæmi, Myeloid, Akut

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AbbVie

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En undersøgelse til vurdering af sikkerhed og tolerabilitet af CC-486 (ONUREG®, oral azacitidin) i kombinationsterapi hos deltagere med akut myeloid leukæmi (AML) (OMNIVERSE)

Leukæmi, Myeloid, Akut

Forenede Stater, Australien

Kliniske forsøg med S241656

Institut de Recherches Internationales Servier

Rekruttering

En undersøgelse af BDTX-4933 hos patienter med BRAF og udvalgte RAS/MAPK-mutationspositive kræftformer

Kolorektal cancer | NSCLC | Solid tumor | Metastatisk lungekræft | Metastatisk lunge ikke-småcellet karcinom | Ikke-småcellet lungekræft | Histiocytose | Skjoldbruskkirtel karcinom | Kræft i skjoldbruskkirtlen | Hjernemetastaser | Tilbagevendende histiocytisk og dendritisk celle-neoplasma | Kolorektalt karcinom | Fast... og andre forhold

Hong Kong, Forenede Stater, Japan, Det Forenede Kongerige, Danmark

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

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

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Datoer for undersøgelser

Studer store datoer

Studiestart (Anslået)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

IPD-delingstidsramme

IPD-delingsadgangskriterier

IPD-deling Understøttende informationstype

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Kliniske forsøg med Akut myeloid leukæmi

Kliniske forsøg med S241656

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in India

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer