NCT06533761

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Stelexis BioSciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• AML, Adult
• MDS

Interventions

Type	Name	Description
DRUG	Eganelisib	eganelisib will be administered as monotherapy
DRUG	Eganelisib in combination with cytarabine	eganelisib will be administered in combination with cytarabine

Timeline

• Start date: 2025-04-28
• Primary completion: 2027-07-15
• Completion: 2028-03-15
• First posted: 2024-08-01
• Last updated: 2025-10-22

Locations

13 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study