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

NCT06533761 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-10-22

No results posted yet for this study

Summary

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

Conditions

  • AML, Adult
  • MDS

Interventions

DRUG

Eganelisib

eganelisib will be administered as monotherapy

DRUG

Eganelisib in combination with cytarabine

eganelisib will be administered in combination with cytarabine

Sponsors & Collaborators

  • Stelexis BioSciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2027-07-15
Completion
2028-03-15
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533761 on ClinicalTrials.gov