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NCT06533761 · ClinicalTrials.gov registry record · Phase 1
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
A Phase 1 study of MDS and AML, Adult, sponsored by Stelexis BioSciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
- 13
- Study locations
NCT06533761: Recruiting Phase 1 study of MDS and AML, Adult, sponsored by Stelexis BioSciences.
NCT06533761 is a Phase 1 study of MDS and AML, Adult that is actively recruiting participants, run by Stelexis BioSciences. The registered enrollment target is 125 participants, above the 91-participant average among 22 other MDS trials with a reported enrollment target (37% higher). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06533761, a Phase 1 study of MDS and AML, Adult, is actively recruiting participants, sponsored by Stelexis BioSciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
- 13
- Study locations
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 Studied
Interventions
- DRUG Eganelisib
- DRUG Eganelisib in combination with cytarabine
Study Locations (13)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center - New York
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Other
- Hospital San Pedro de Alcántara - Cáceres
- Hospital Universitari i Politècnic La Fe - Valencia
California
- City of Hope - Duarte
Colorado
- Anshutz Cancer Pavilion - Aurora
Florida
- Moffitt Cancer Center - Tampa
Massachusetts
- Dana-Farber Cancer Institute - Boston
Missouri
- Washington University in St Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-04-28 |
| Est. Completion | 2028-03-15 |
| Phase | Phase 1 |
What NCT06533761 shows while recruiting
NCT06533761 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, above the 91-participant average among 22 other MDS trials with a reported enrollment target (37% higher).
The record links to 2 conditions, with MDS appearing as the primary indexed condition, and to 2 interventions - of which Eganelisib is the first listed.
NCT06533761 lists 13 locations in 9 states (New York, Ohio, Other).
Frequently Asked Questions
What is clinical trial NCT06533761 about?
NCT06533761 is a clinical study titled "Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML". 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/refra...
What is the current status of trial NCT06533761?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2025-04-28. Estimated completion is 2028-03-15.
What conditions does trial NCT06533761 study?
This clinical trial studies the following conditions: MDS, AML, Adult.
What interventions are being tested in trial NCT06533761?
The interventions under investigation include: Eganelisib (DRUG), Eganelisib in combination with cytarabine (DRUG).
Who is sponsoring clinical trial NCT06533761?
This trial is sponsored by Stelexis BioSciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06533761 being conducted?
This trial has 13 study locations across California, Colorado, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06533761's enrollment target sits among peer trials
125 4th of 22 higher than 19 of 22 other MDS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other MDS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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