A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies

Completed · Phase 1

Conditions studied: Advanced Cancer, Solid Tumor, Adult, B-cell Lymphoma, Adult

In brief

This is an open-label, non-randomized, Phase 1 study to determine the safety, tolerability, and preliminary efficacy of MCLA-145 in adult patients with advanced metastatic solid tumors or B-cell lymphomas. The study will be conducted in 2 parts.

Key facts

Study ID

NCT03922204

Run by

Merus B.V.

People needed

72

Starts

2019-05-08

Expected to finish

2024-11-07

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors or B-cell lymphomas, that are considered non-amenable to surgery or other curative treatments or procedures (if applicable)
• Measureable disease per RECIST v1.1 or Lugano Criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Received prior standard therapy for advanced or recurrent/metastatic disease as applicable to tumor type
• Received a maximum of 4 prior systemic treatment regimens (inclusive of chemotherapy, immunotherapy, and targeted therapy regimens) for advanced or recurrent/metastatic disease
• Life expectancy of ≥12 weeks, as per investigator judgement

You may not qualify if…

• The following B-cell neoplasms: Burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia
• Prior therapy containing an anti-PD-L1 agent or T-cell agonist
• Current serious illness or medical condition including, but not limited to uncontrolled active infection
• Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting MCLA-145
• Prior ≥ Grade 3 immune-mediated AEs with anti-PD-1 therapy
• History of any grade immune-mediated ocular AEs.
• Known hypersensitivity or severe reaction to any component of MCLA-145 or formulation components
• Participants who have active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)

Where it is running

• Moores Cancer Centre — La Jolla, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospital Antwerp — Antwerp, Edegem, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Netherlands Cancer Institute — Amsterdam, Netherlands
• Hospital Universitario Fundarcion Jimenez Diaz — Madrid, Spain
• Clinica Universidad de Navarra — Pamplona, Spain

Full record on ClinicalTrials.gov

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