clinical trial · NCT06533761
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Stelexis BioSciences·phase1·recruiting·n = 125
AML, AdultMDSEganelisibEganelisib in combination with cytarabine
brief 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
started
Apr 28, 2025
primary completion
Jul 15, 2027
completion
Mar 15, 2028
last updated
Aug 25, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol