OncoMatch

OncoMatch/Clinical Trials/NCT06533761

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

Is NCT06533761 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Eganelisib and Eganelisib in combination with cytarabine for aml, adult.

Phase 1RecruitingStelexis BioSciencesNCT06533761Data as of Jun 2026Location: United States · Spain

Treatment: Eganelisib · Eganelisib in combination with cytarabineThis 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

Check if I qualify

Extracted eligibility criteria

Treatments studied

Other

EganelisibEganelisib in combination with cytarabine

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: stem cell transplant

Exception: allowed if >6 months prior to Cycle 1 Day 1

Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1

Lab requirements

Kidney function

Adequate renal function measured within 7 days prior to the first dose of eganelisib

Liver function

Adequate hepatic function measured within 7 days prior to the first dose of eganelisib

Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • Anshutz Cancer Pavilion · Aurora, Colorado
  • Moffitt Cancer Center · Tampa, Florida
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • Washington University in St Louis · St Louis, Missouri

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06533761 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior stem cell transplant disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify