Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-07-30; most recent amendment 2025-10-20.
Status change: Not Yet Recruiting → Recruiting 2025-05-13
Trial Details
NCT Number NCT06533761
Lead Sponsor Stelexis BioSciences
Conditions AML, Adult, MDS
Enrollment 125 participants
Start Date 2025-04-28
Primary Completion 2027-07-15 (estimated)
Study Completion 2028-03-15 (estimated)
Updated on ClinicalTrials.gov 2025-10-22