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NCT07672769
Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes
Conditions: Higher Risk Myelodysplastic Syndromes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: Faron Pharmaceuticals Ltd
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Participant provides written informed consent.
2. Participant is ≥18 years of age.
3. Participant has newly diagnosed MDS with morphologically confirmed HR-MDS as defined according to 2022 World Health Organization classification (5th Edition, Annex 7).
1. IPSS-M classification of moderately high risk, high risk, and very high risk.
2. \3×ULN\]); persistent chronic ulcers with high risk of infection per investigator's assessment.
12. Participant has received recent non-MDS related anticancer therapy or investigational agents within drug-specified washout periods (e.g., \
Source: ClinicalTrials.gov (NCT07672769). StuddyBuddy aggregates publicly available trial information.
