The trial is taking place at:

Clinica Universidad de Navarra | Sede Madrid - Hematology Department

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



Status and phase

Phase 1


Advanced Cancer
Solid Tumor, Adult
B-cell Lymphoma, Adult


Drug: MCLA-145

Study type


Funder types



2018-004396-13 (EudraCT Number)

Details and patient eligibility


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

Full description

Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion. Part 2 is a dose expansion to confirm the dose of MCLA-145 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement. The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment( first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30 days and 90 days after the last dose) including survival follow-up checks every 2 months up to 12 months after the last dose.


118 estimated patients




18+ years old


No Healthy Volunteers

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)

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

118 participants in 1 patient group

Experimental group
In Part 1, the dose escalation phase, patients with advanced or recurrent/metastatic solid tumors or B-cell lymphomas will receive escalating doses of MCLA-145 ( every 2 weeks ) until MTD or RDE is reached. In Part 2, the expansion phase, participants with advanced or metastatic solid tumors will receive intravenous infusion of MCLA-145 at the recommended phase II dose every 2 weeks. The duration of each treatment cycle is 28 days
Drug: MCLA-145

Trial contacts and locations



Central trial contact

Gianluca Laus, MD; Andrew Joe, MD

Data sourced from

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