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
Stelexis BioSciences
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Adequate hepati…
Interventions
- DrugEganelisib
eganelisib will be administered as monotherapy
- DrugEganelisib in combination with cytarabine
eganelisib will be administered in combination with cytarabine
Locations (13)
- City of HopeDuarte, California
- Anshutz Cancer PavilionAurora, Colorado
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Washington University in St LouisSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York