Recruiting
Phase 1

Eganelisib & Cytarabine

Sponsor:

Stelexis BioSciences

Code:

NCT06533761

Conditions

AML, Adult

MDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eganelisib

Eganelisib in combination with cytarabine

Study Details

Brief 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

Study ID

NCT06533761

Start date

Apr 28, 2025

Status verified date

Aug, 2026

Completion date

Mar 15, 2028

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eganelisib

experimental: Eganelisib in combination with cytarabine

Interventions

Eganelisib

eganelisib will be administered as monotherapy

Eganelisib in combination with cytarabine

eganelisib will be administered in combination with cytarabine

Primary outcome measure

  • Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 [ Time Frame: 12 months ]
  • Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1 [ Time Frame: 28-35 days ]
  • Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Office Stelexis

508-543-6979clinicaltrials@stelexis.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Shukaib Arslan

626-218-1133sarslan@coh.org

Anshutz Cancer Pavilion

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Derek Schatz

DEREK.SCHATZ@CUANSCHUTZ.EDU

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Wes Mungal

813-745-0851Wesley.Mungal@moffitt.org

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Megan Forsyth

857-215-1405Megan_Forsyth@DFCI.Harvard.edu

Washington University in St Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Na'kie Coleman-Elhasan

314-454-8708nakie@wustl.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Anmol Shah

646-608-2813shaha10@mskcc.org

Montefiore Medical Center

Recruiting

New York, New York, United States, 10466

Contacts

Davina Hoban

201-618-4725davinahoban@montefiore.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Ibraheem Al-Aref

216-442-0461ali3@ccf.org

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Sarah Mayne

614-685-9573sarah.mayne@osumc.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Meagan Sachs

713-503-1589msachs@mdanderson.org

More Information

Sponsor

Stelexis BioSciences

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stelexis BioSciences on 2026-08-25.