OncoMatch/Clinical Trials/NCT06533761
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS
Official title: 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 or Higher Risk Myelodysplastic Syndrome and Eganelisib in Combination With Azacitidine in PI3K-Gamma-Positive Patients With Previously Untreated Higher Risk Myelodysplastic Syndrome
Is NCT06533761 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including Eganelisib and Eganelisib in combination with cytarabine for aml, adult.
Treatment: Eganelisib · Eganelisib in combination with cytarabine · Eganelisib in combination with azacitidine · Azacitadine (AZA) — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: PIK3CG expression (moderate or higher)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
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.
Does this trial require PIK3CG?
Yes, PIK3CG expression is a required biomarker for 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