NCT06533761 Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
| NCT ID | NCT06533761 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stelexis BioSciences |
| Condition | AML, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 125 participants in total. It began in 2025-04-28 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06533761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06533761 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06533761 currently recruiting?
Yes, NCT06533761 is actively recruiting participants. Contact the research team at clinicaltrials@stelexis.com for enrollment information.
Where is the NCT06533761 trial being conducted?
This trial is being conducted at Duarte, United States, Aurora, United States, Tampa, United States, Boston, United States and 9 additional locations.
Who is sponsoring the NCT06533761 clinical trial?
NCT06533761 is sponsored by Stelexis BioSciences. The trial plans to enroll 125 participants.