Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies
Lead Sponsor:
Faron Pharmaceuticals Ltd
Conditions:
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 leuke...
Detailed Description
This is a multicenter Phase 1/2 open-label, study to assess the safety, tolerability and preliminary efficacy of increasing doses of bexmarilimab (FP-1305) in patients with intermediate, high or very ...
Eligibility Criteria
Inclusion
- Patient ≥ 18 years of age who presents with one of the following conditions:
- Morphologically confirmed diagnosis of MDS with revised International Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very high.
- Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine treatment.
- CMML and MDS patient with response failure to HMA or therapy regimen including HMA.
- Morphologically confirmed diagnosis of r/r AML following at least 1 line of prior therapies with indication for azacitidine treatment.
- Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment.
- Leukocyte count \< 20 x10\^9/L (\< 25 x10\^9/L for newly diagnosed AML). Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in CMML.
- Adequate renal function.
- Adequate liver function.
Exclusion
- Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count \> 13 x10\^9/L.
- Eastern Cooperative Oncology Group (ECOG) performance status \>2 (except newly diagnosed AML where ECOG 3 is allowed for patients \< 75 years).
- Allogeneic transplantation less than 6 months prior screening.
- Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia).
- The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment.
- Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than 14 days or five half-lives (whichever is shorter) from a small molecule targeted therapy or oral anticancer chemotherapy before the first study treatment.
- Any immunotherapy or investigational therapy within preceding 28 days from the first study treatment.
- Pregnant or lactating women.
- History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT05428969
Start Date
June 2 2022
End Date
April 1 2026
Last Update
December 1 2025
Active Locations (10)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
3
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
4
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030