A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Faron Pharmaceuticals Ltd
Study ID
NCT05428969
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bexmarilimab — DRUG
    Intravenous
  • Azacitidine — DRUG
    As per label, subcutaneous
  • Venetoclax — DRUG
    Oral

Study Details

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.

Key Dates

Start date
Jun 2, 2022
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
181 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 - Intermediate/high risk MDS, CMML 10-19%, MDS/CMML failure to HMA, r/r AML
    Standard of care azacitidine as per label; bexmarilimab 4 dose levels at once every week (Q1W) followed by once every 2 weeks (Q2W); 28-day cycle
  • Experimental: Phase 1 - Newly diagnosed AML patients non-fit for induction therapy
    Standard of care azacitidine and venetoclax as per label; bexmarilimab 4 dose levels Q1W followed by Q2W; 28-day cycle
  • Experimental: Phase 2 - Intermediate/high risk MDS, CMML, MDS/CMML failure to HMA, r/r AML & newly diagnosed AML
    Standard of care venetoclax and/or azacitidine as per label plus bexmarilmab

Primary Outcome Measure

Reporting of incidence and frequency of dose limiting toxicities (DLTs). [ Time Frame: From study start to end of Cycle 1 (each cycle is 28 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Yale Cancer CenterNew HavenConnecticut06510-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
University of Texas, MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CAYale Cancer Center· New Haven, CTUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCUniversity of Texas, MD Anderson Cancer Center· Houston, TX

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