RecruitingPhase 1NCT06533761

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


Sponsor

Stelexis BioSciences

Enrollment

125 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests eganelisib — a drug that targets an enzyme called PI3K-gamma that helps cancer cells evade the immune system — either alone or combined with cytarabine (a standard chemotherapy drug) for adults with relapsed/refractory AML (acute myeloid leukemia) or high-risk MDS (myelodysplastic syndromes, a condition where bone marrow produces abnormal blood cells). Both conditions involve the bone marrow not making healthy blood cells properly, and this study tests a new approach for patients who have run out of standard options. **You may be eligible if...** - You have relapsed or refractory AML or high-risk MDS with 10% or more abnormal cells (blasts) in your bone marrow - You are in reasonably good health (ECOG score 0-2) - Your liver and kidney function are adequate **You may NOT be eligible if...** - You had a stem cell transplant within the past 6 months - You are on immunosuppressants or systemic steroids (except for adrenal replacement) - You have an active fungal infection or any uncontrolled infection, or were not fever-free and stable for at least 72 hours on antibiotics - Your white blood cell count is very high (>25 × 10⁹/L) before treatment - You have unresolved significant side effects from prior therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Hope

Duarte, California, United States

Anshutz Cancer Pavilion

Aurora, Colorado, United States

Moffitt Cancer Center

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University in St Louis

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Hospital San Pedro de Alcántara

Cáceres, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06533761


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