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

Phase 1

Recruiting

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

• Registration Number: NCT05428969
• Lead Sponsor: Faron Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-6-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient = 18 years of age who presents with one of the following conditions:<br><br> - Morphologically confirmed diagnosis of MDS with revised International<br> Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very<br> high.<br><br> - Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine<br> treatment.<br><br> - CMML and MDS patient with response failure to HMA or therapy regimen including<br> HMA.<br><br> - Morphologically confirmed diagnosis of r/r AML following at least 1 line of<br> prior therapies with indication for azacitidine treatment.<br><br> - Morphologically confirmed diagnosis of AML in patients unfit for induction<br> therapy with indication for azacitidine-venetoclax treatment.<br><br> - Leukocyte count < 20 x10^9/L (< 25 x10^9/L for newly diagnosed AML).<br> Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in<br> CMML.<br><br> - Adequate renal function.<br><br> - Adequate liver function.<br><br>Exclusion Criteria:<br><br> - Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as<br> defined by leukocyte count > 13 x10^9/L.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status >2 (except newly<br> diagnosed AML where ECOG 3 is allowed for patients < 75 years).<br><br> - Allogeneic transplantation less than 6 months prior screening.<br><br> - Patient with active auto-immune disorder (except type I diabetes, celiac disease,<br> hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or<br> alopecia).<br><br> - The patient requires systemic corticosteroid (=10 mg/day prednisone or equivalent)<br> or other immunosuppressive treatment.<br><br> - Less than 21 days since the last dose of intravenous anticancer chemotherapy or less<br> than 14 days or five half-lives (whichever is shorter) from a small molecule<br> targeted therapy or oral anticancer chemotherapy before the first study treatment.<br><br> - Any immunotherapy or investigational therapy within preceding 28 days from the first<br> study treatment.<br><br> - Pregnant or lactating women.<br><br> - History of chronic ulcers or clinically relevant liver disease leading to Child Pugh<br> Score C or higher.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reporting of incidence and frequency of dose limiting toxicities (DLTs).;Frequency and severity based on NCI-CTCAE grading of treatment emergent AEs and serious adverse events (SAE).;Complete response (CR) rate for MDS and CMML-2.;Overall response rate (ORR) for MDS and CMML failure to prior HMA.;Complete remission with incomplete blood recovery (CRi) for r/r AML.;Minimal residual disease (MRD) status for newly diagnosed AML.

Secondary Outcome Measures

Name	Time	Method
Frequency and severity based on NCI-CTCAE grading of treatment emergent AEs and SAEs.;Clinical efficacy measures based on progression free survival analyses defined as the time from study start to the date of documented disease progression or death from any cause, whichever occurs first, up to 2 years.;Clinical efficacy measures based on overall survival analyses defined as the length measured from study start to death from any cause up to 2 years.;Anti-bexmarilimab antibody positivity occurrence rate pre-dose and at defined timepoints during treatment.;Serum concentrations of bexmarilimab at defined timepoints pre-dose and post-dose of single and repeat bexmarilimab administrations using peripheral blood.