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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


Description

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.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 high-risk MDS, CMML with 10-19 % marrow blasts, CMML/MDS with failure to hypomethylating agent (HMA), or in patients with newly diagnosed AML non-fit for induction therapy or relapsed/refractory AML. The Phase 1 part of the study will identify a safe and tolerable bexmarilimab dose amongst four predefi

Trial Eligibility

Inclusion Criteria: * 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 Criteria: * 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.

Study Info

Organization

Faron Pharmaceuticals Ltd


Primary Outcome

Reporting of incidence and frequency of dose limiting toxicities (DLTs).


Outcome Timeframe From study start to end of Cycle 1 (each cycle is 28 days)

NCTID NCT05428969

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2022-06-02

Completion Date 2025-04-01

Enrollment Target 181

Interventions

DRUG Bexmarilimab

DRUG Azacitidine

DRUG Venetoclax

Locations Recruiting

City of Hope National Medical Center

United States, California, Duarte


Yale Cancer Center

United States, Connecticut, New Haven


UNC Lineberger Comprehensive Cancer Center

United States, North Carolina, Chapel Hill


University of Texas, MD Anderson Cancer Center

United States, Texas, Houston


Helsinki University Hospital

Finland, Helsinki


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