Status:
RECRUITING
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Lead Sponsor:
Stelexis BioSciences
Conditions:
AML, Adult
MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 effi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06533761
Start Date
April 28 2025
End Date
March 15 2028
Last Update
October 22 2025
Active Locations (13)
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1
City of Hope
Duarte, California, United States, 91010
2
Anshutz Cancer Pavilion
Aurora, Colorado, United States, 80045
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215