A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
Bexmarilimab: Intravenous
Azacitidine: As per label, subcutaneous
Venetoclax: Oral
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.
Eligibility
Primary outcome measure(s)
- Reporting of incidence and frequency of dose limiting toxicities (DLTs). — From study start to end of Cycle 1 (each cycle is 28 days)
- Frequency and severity based on NCI-CTCAE grading of treatment emergent AEs and serious adverse events (SAE). — From study start to 30 days after end of treatment (EOT)
- Complete response (CR) rate for MDS and CMML-2. — From study start to 30 days after EOT
- Overall response rate (ORR) for MDS and CMML failure to prior HMA. — From study start to 30 days after EOT
- Complete remission with incomplete blood recovery (CRi) for r/r AML. — From study start to 30 days after EOT
- Minimal residual disease (MRD) status for newly diagnosed AML. — From study start to 30 days after EOT
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | |
| Yale Cancer Center | New Haven | Connecticut | |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | |
| University of Texas, MD Anderson Cancer Center | Houston | Texas | |
| 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 |
On this site
📄 Venclexta (venetoclax) drug profile →More Faron Pharmaceuticals Ltd trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05428969 on ClinicalTrials.gov ↗ ← All trials in the USA