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 (BEXMAB)

NCT05428969 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Faron Pharmaceuticals Ltd
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	181
Start date	2022-06-02
Completion	2027-03

Conditions

• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Myelodysplastic Syndromes
• Relapsed/Refractory AML

Interventions

• Bexmarilimab
• Azacitidine
• Venetoclax

Primary outcomes

• 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

Countries

United States, Finland, United Kingdom