A Phase 1b Open-Label Study To Evaluate The Safety And Tolerability Of Eganelisib As Monotherapy And In Combination With Cytarabine In Patients With Relapsed/Refractory Acute Myeloid Leukemia Or Higher Risk Myelodysplastic Syndrome And Eganelisib In Combination With Azacitidine In PI3K-Gamma-Positive Patients With Previously Untreated Higher Risk Myelodysplastic Syndrome

Description

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

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT06533761 Opens a new window