A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies
About the study
This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of MCLA-145 in advanced or metastatic malignancies
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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)
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Cancer,Solid Tumor, Adult,B-cell Lymphoma, Adult
Age (in years)
18+
Phase
Phase 1
Participants needed
118
Est. Completion Date
Dec 31, 2022
Treatment type
Interventional
Sponsor
Merus N.V.
ClinicalTrials.gov identifier
NCT03922204
Study number
MCLA-145-CL01/MCLA-145-101
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