Status: Recruiting
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
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
Participants needed: 125
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Stelexis BioSciencesUpdated: Aug 25, 2026Locations: 13
Eligibility criteria
Pathological diagnosis of either: AML according to World Health Organization (WH... [+2]
Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 D... [+4]