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ACTIVE NOT RECRUITING
NCT05428969
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Bexmarilimab

Intravenous

DRUG

Azacitidine

As per label, subcutaneous

DRUG

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