Acute Myeloid LeukemiaPhase 1/2NCT07719348
A Study to Evaluate S241656 Alone or in Combination in Participants With Selected Myeloid Malignancies
A Phase 1/2 study testing S241656 and Posaconazole in people with Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, run by Servier.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome Acute Myeloid Leukemia
- What is being tested?
- S241656 and Posaconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Institut de Recherches Internationales Servier (I.R.I.S.) contact
About this study
Official title: 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.
- Conditions
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome Acute Myeloid Leukemia
- Being tested
- S241656, Posaconazole
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, GATA2 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S241656Drug
Tablets taken by mouth.
PosaconazoleDrug
Tablets taken by mouth
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Dose Escalation | Experimental | Not described Receives: Drug: S241656 |
| Part 1B: Optional Drug-Drug Interaction [DDI] Substudy | Experimental | Not described Receives: Drug: S241656; Drug: Posaconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment
Measured: Through Cycle 1 (28 days)
(Part 1A and 1B) Number of Adverse Events (AEs)
Measured: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of Serious Adverse Events (SAEs)
Measured: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Severity of AEs
Measured: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Severity of SAEs
Measured: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of AEs
Measured: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of SAEs
Measured: 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
Measured: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of changes in physical examination
Measured: 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
Measured: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose interruptions due to AEs
Measured: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose delays due to AEs
Measured: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of study withdrawals due to AEs
Measured: Through end of treatment, up to approximately 4 years
(Part 1B only) Maximum concentration (Cmax) of S241656
Measured: Through Cycle 1 (28 days)
(Part 1B only) Cmax of metabolite S243796
Measured: Through Cycle 1 (28 days)
(Part 1B only) Time corresponding to Cmax (Tmax) of S241656
Measured: Through Cycle 1 (28 days)
(Part 1B only) Tmax of metabolite S243796
Measured: Through Cycle 1 (28 days)
(Part 1B only) Terminal half-life (t1/2) of S241656
Measured: Through Cycle 1 (28 days)
(Part 1B only) t1/2 of metabolite S243796
Measured: Through Cycle 1 (28 days)
(Part 1B only) Area under the curve (AUC) of S241656
Measured: Through Cycle 1 (28 days)
(Part 1B only) AUC of metabolite S243796
Measured: Through Cycle 1 (28 days)
Secondary outcomes (22)
(Part 1A only) Cmax of S241656
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) Cmax of metabolite S243796
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of S241656
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of metabolite S243796
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of S241656
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of metabolite S243796
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) t1/2 of S241656
Measured: Through end of treatment, up to approximately 4 years
(Part 1A only) t1/2 of metabolite S243796
Measured: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Complete remission (CR)
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with incomplete hematologic recovery (CRi)
In participants with AML or MDS/AML only
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Morphologic leukemia free state (MLFS)
In participants with AML or MDS/AML only
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with partial hematologic recovery (CRh)
In participants with AML or MDS/AML only
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Partial response (PR)
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Objective response (OR)
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Composite complete remission (CRc)
In participants with AML or MDS/AML only
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Red blood cell (RBC) and platelet transfusion independence for at least 8 weeks
In participants with AML or MDS/AML only
Measured: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of response (DOR)
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Time to response (TTR)
In participants with AML or MDS/AML only
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Event free survival (EFS)
In participants with AML or MDS/AML only
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Overall survival (OS)
Measured: Through study completion, approximately 4 years
(Part 1A and 1B) Marrow response
In participants with CMML only
Measured: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of participants with erythroid-, neutrophil-, platelet or spleen-response
In participants with CMML only
Measured: Through end of treatment, up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servier
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719348
- Sponsor's protocol ID
- S241656-292
- Other IDs
- 2025-525128-88-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07719348
- Acronym / sponsor ID
- S241656-292
- Conditions
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- ServierIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Dose Escalation | Experimental | Drug: S241656 |
| Part 1B: Optional Drug-Drug Interaction [DDI] Substudy | Experimental | Drug: S241656, Drug: Posaconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S241656Tablets taken by mouth. | Drug | Part 1A: Dose Escalation, Part 1B: Optional Drug-Drug Interaction [DDI] Substudy |
| PosaconazoleTablets taken by mouth | Drug | Part 1B: Optional Drug-Drug Interaction [DDI] Substudy |
Primary outcome
(Part 1A and 1B) Dose limiting toxicity (DLTs) associated with S241656 during the first cycle of treatment
Time frame: Through Cycle 1 (28 days)
(Part 1A and 1B) Number of Adverse Events (AEs)
Time frame: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of Serious Adverse Events (SAEs)
Time frame: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Severity of AEs
Time frame: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Severity of SAEs
Time frame: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of AEs
Time frame: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of SAEs
Time frame: 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
Time frame: Through 30 days after the last dose of treatment, up to approximately 4 years
(Part 1A and 1B) Number of changes in physical examination
Time frame: 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
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose interruptions due to AEs
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of dose delays due to AEs
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of study withdrawals due to AEs
Time frame: Through end of treatment, up to approximately 4 years
(Part 1B only) Maximum concentration (Cmax) of S241656
Time frame: Through Cycle 1 (28 days)
(Part 1B only) Cmax of metabolite S243796
Time frame: Through Cycle 1 (28 days)
(Part 1B only) Time corresponding to Cmax (Tmax) of S241656
Time frame: Through Cycle 1 (28 days)
(Part 1B only) Tmax of metabolite S243796
Time frame: Through Cycle 1 (28 days)
(Part 1B only) Terminal half-life (t1/2) of S241656
Time frame: Through Cycle 1 (28 days)
(Part 1B only) t1/2 of metabolite S243796
Time frame: Through Cycle 1 (28 days)
(Part 1B only) Area under the curve (AUC) of S241656
Time frame: Through Cycle 1 (28 days)
(Part 1B only) AUC of metabolite S243796
Time frame: Through Cycle 1 (28 days)
22 secondary outcomes
(Part 1A only) Cmax of S241656
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) Cmax of metabolite S243796
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of S241656
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) Tmax of metabolite S243796
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of S241656
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) AUC of metabolite S243796
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) t1/2 of S241656
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A only) t1/2 of metabolite S243796
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Complete remission (CR)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with incomplete hematologic recovery (CRi)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Morphologic leukemia free state (MLFS)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Complete remission with partial hematologic recovery (CRh)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Partial response (PR)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Objective response (OR)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Composite complete remission (CRc)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Red blood cell (RBC) and platelet transfusion independence for at least 8 weeks
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Duration of response (DOR)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Time to response (TTR)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Event free survival (EFS)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Overall survival (OS)
Time frame: Through study completion, approximately 4 years
(Part 1A and 1B) Marrow response
Time frame: Through end of treatment, up to approximately 4 years
(Part 1A and 1B) Number of participants with erythroid-, neutrophil-, platelet or spleen-response
Time frame: Through end of treatment, up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
Study of REM-422 in Patients With AML or Higher Risk MDS
Myelodysplastic Syndromes, Higher Risk Myelodysplastic Syndromes
Not yet recruiting
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
Sarcoma, Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut de Recherches Internationales Servier (I.R.I.S.) contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S241656 and Posaconazole in people with Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, run by Servier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Institut de Recherches Internationales Servier (I.R.I.S.) (+33 1 55 72 60 00, scientificinformation@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.