Study #2025-0074
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
MD Anderson Study Status
Enrolling
Treatment Agent
Eganelisib, Eganelisib in combination with cytarabine, Eganelisib in combination with azacitidine, Azacitadine (AZA)
Description
This is a Phase 1b open-label, multicenter, dose-escalation and randomized combination cohort 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) and in combination with azacitidine in PI3K-Gamma-Positive patients with previously untreated HR-MDS. The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination with cytarabine. * Part 2: Randomized Combination Cohort: eganelisib + azacitidine and azacitidine alone
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
AML, Adult, MDS
Study phase:
Phase I
Physician name:
Tapan Kadia
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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