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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eganelisib
  • Drug: Eganelisib
    eganelisib will be administered as monotherapy
  • Drug: Eganelisib in combination with cytarabine
    eganelisib will be administered in combination with cytarabine
Experimental
Eganelisib in combination with cytarabine
  • Drug: Eganelisib in combination with cytarabine
    eganelisib will be administered in combination with cytarabine

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University in St Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Na'kie Coleman-Elhasan
314-454-8708
nakie@wustl.edu

More Details

NCT ID
NCT06533761
Status
Recruiting
Sponsor
Stelexis BioSciences

Study Contact

Clinical Trials Office Stelexis
508-543-6979
clinicaltrials@stelexis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.