Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03922204
Eligibility 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:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03922204
Study Brief:
Protocol Section:
NCT03922204