Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Trial Parameters
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
Eligibility Criteria
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 hepatic and renal function measured within 7 days prior to the first dose of eganelisib. Exclusion Criteria: * Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1. * Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency). * Active fungal disease or uncontrolled infect