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NCT05428969 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Faron Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 181
- Enrollment target
- 10
- Study locations
NCT05428969: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Faron Pharmaceuticals.
NCT05428969 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Faron Pharmaceuticals. The registered enrollment target is 181 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% higher). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05428969, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Faron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 181 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Bexmarilimab
Study Locations (10)
Other
- Helsinki University Hospital - Helsinki
- Kuopio University Hospital - Kuopio
- Oulu University Hospital - Oulu
- Tampere University Hospital - Tampere
- The Christie NHS Foundation Trust - Manchester
- Royal Cornwall Hospitals NHS Trust - Truro
California
- City of Hope National Medical Center - Duarte
Connecticut
- Yale Cancer Center - New Haven
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Texas
- University of Texas, MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
What the registry record for NCT05428969 still lists
NCT05428969 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% higher).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05428969 lists 10 locations in 5 states (Other, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT05428969 about?
NCT05428969 is a clinical study titled "A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies". This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (R...
What is the current status of trial NCT05428969?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 181 participants. The study started on 2022-06-02. Estimated completion is 2026-04.
What conditions does trial NCT05428969 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Relapsed/Refractory AML.
What interventions are being tested in trial NCT05428969?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Bexmarilimab (DRUG).
Who is sponsoring clinical trial NCT05428969?
This trial is sponsored by Faron Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05428969 being conducted?
This trial has 10 study locations across California, Connecticut, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05428969's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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