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RECRUITING Phase 1 ClinicalTrials.gov

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS

Sponsor: Stelexis BioSciences • ClinicalTrials.gov ID: NCT06533761

Registry updated: 2026-10-20
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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

Interventions

  • Eganelisib (Drug)
    eganelisib will be administered as monotherapy
  • Eganelisib in combination with cytarabine (Drug)
    eganelisib will be administered in combination with cytarabine
  • Eganelisib in combination with azacitidine (Drug)
    eganelisib will be administered in combination with azacitidine
  • Azacitadine (AZA) (Drug)
    azacitidine will be administered as standard of care

Eligibility criteria

Inclusion Criteria: * Part 1: 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. * Part 2: Pathological diagnosis of previously untreated HR-MDS according to WHO 2022 revised criteria, with bone marrow blasts ≥5% and \<20%; Moderate or higher PI3K-Gamma in bone marrow blasts, as determined by an IHC assay; Deemed by the Investigator to require frontline therapy with azacitidine. * 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 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.

Conditions

AML, Adult MDS

Locations

  • 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
  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record