NCT07439211

Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia

Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Jacqueline Garcia, MD · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML). The names of the study drugs involved in this research study are: * Venetoclax (a type of BCL-2 inhibitor) * Azacitidine (a type of Demethylating Agent) * Eganelisib (a type of PI3K-gamma inhibitor)

Detailed description

This phase 1 clinical trial is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML). The dose-escalation portion of the trial will aim to establish the maximum tolerated dose of the drug, eganelisib, for the recommended phase 2 dose. The dose-expansion portion of the trial will aim to confirm the recommended phase 2 dose of the drug, eganelisib. The U.S. Food and Drug Administration (FDA) has not approved eganelisib as a treatment for acute myeloid leukemia. The FDA has approved azacitidine and venetoclax as a treatment option for AML. However, the combination of these two drugs with eganelisib (three drug or triplet regimen) has not been FDA approved. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, electrocardiograms (ECGs), and bone marrow biopsies and aspirations. It is expected that up to 48 people will take part in this research study. Stelexis BioSciences, Inc. is supporting this study by providing funding and the study drug, eganelisib.

Conditions

• Leukemia, Myeloid
• Leukemia
• Acute Myeloid Leukemia
• Refractory Leukemia

Interventions

Type	Name	Description
DRUG	Eganelisib	PI3K-gamma inhibitor, capsule taken orally per protocol.
DRUG	Azacitidine	Demethylating Agent, single use vial, via subcutaneous (under the skin) injection or intravenous (into the vein) infusion per standard of care.
DRUG	Venetoclax	BCL-2 inhibitor, tablet taken orally per standard of care.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-02-01
• Completion: 2029-02-01
• First posted: 2026-02-27
• Last updated: 2026-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study