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A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies
Sponsor: Faron Pharmaceuticals Ltd
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.
Official title: A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination With Standard of Care Therapy in Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
181
Start Date
2022-06-02
Completion Date
2026-04
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Bexmarilimab
Intravenous
Azacitidine
As per label, subcutaneous
Venetoclax
Oral
Locations (10)
City of Hope National Medical Center
Duarte, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom