Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Recruiting now · Phase 1

Conditions studied: AML, Adult, MDS

In brief

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

Key facts

Study ID

NCT06533761

Run by

Stelexis BioSciences

People needed

125

Starts

2025-04-28

Expected to finish

2028-03-15

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for >72 hours prior to treatment
• WBC count >25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
• Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.

Where it is running

• Hospital Universitari i Politècnic La Fe — Valencia, Spain (enrolling)
• Anshutz Cancer Pavilion — Aurora, Colorado, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Washington University in St Louis — St Louis, Missouri, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Montefiore Medical Center — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Hospital San Pedro de Alcántara — Cáceres, Spain (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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