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

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

Trial Details

NCT ID
NCT06533761
Phase
PHASE1
Sponsor
Stelexis BioSciences
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Eganelisib
  • Eganelisib in combination with cytarabine
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Tampa, Florida, United States|27.94752,-82.45843
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥1…
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.

For full eligibility, visit ClinicalTrials.gov.

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