Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes
Public ClinicalTrials.gov record NCT07672769. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Bexmarilimab Plus Azacitidine in a Randomized, Double-blind, Placebo-controlled Phase IIb Trial in Treatment-naïve Higher-risk Myelodysplastic Syndromes (HR-MDS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with treatment-naïve higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomized to receive bexmarilimab at one of two dose levels (1 mg/kg or 3 mg/kg) plus azacitidine, or placebo plus azacitidine. The primary aim is to select the recommended dose of bexmarilimab for subsequent development based on a predefined integration of clinical response and safety/tolerability.
Study identification
- NCT ID
- NCT07672769
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- bexmarilimab (1mg/kg) Drug
- azacitidine Drug
- Placebo Drug
- bexmarilimab (3mg/kg) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2026 (Estimated)
- Primary completion
- Nov 2027 (Estimated)
- Completion
- Dec 2030 (Estimated)
- Last update posted
- Oct 20, 2026
2026 – 2030
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Not yet recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | Not yet recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06510 | Not yet recruiting |
| Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System | Pembroke Pines | Florida | 33028 | Not yet recruiting |
| Mass General Brigham Cancer Institute | Boston | Massachusetts | 02114 | Not yet recruiting |
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | Not yet recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Not yet recruiting |
| Medical College of Wisconsin - Clinical Cancer Center - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07672769, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07672769 live on ClinicalTrials.gov.