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Study identifier: NCT06533761 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Condition: AML, Adult · MDS  ·  Sponsor: Stelexis BioSciences

PhasePhase 1
Planned participants125
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS). The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination. * Part 2: Dose Optimization

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Office Stelexis  ·  508-543-6979  ·  clinicaltrials@stelexis.com

Always discuss trial participation with your own doctor first.

Locations (13)

City of HopeDuarte, California, United StatesRecruiting
Anshutz Cancer PavilionAurora, Colorado, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
Washington University in St LouisSt Louis, Missouri, United StatesRecruiting
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesNot Yet Recruiting
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesRecruiting
Montefiore Medical CenterNew York, New York, United StatesRecruiting
Cleveland ClinicCleveland, Ohio, United StatesRecruiting
Ohio State UniversityColumbus, Ohio, United StatesRecruiting
MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Hospital San Pedro de AlcántaraCáceres, SpainRecruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06533761