For Healthcare Professionals

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

clipboard-pencil

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
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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)
  2. Measureable disease per RECIST v1.1 or Lugano Criteria
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Received prior standard therapy for advanced or recurrent/metastatic disease as applicable to tumor type
  5. Received a maximum of 4 prior systemic treatment regimens (inclusive of chemotherapy, immunotherapy, and targeted therapy regimens) for advanced or recurrent/metastatic disease
  6. Life expectancy of ≥12 weeks, as per investigator judgement

EXCLUSION CRITERIA

Exclusion Criteria:

  1. The following B-cell neoplasms: Burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia
  2. Prior therapy containing an anti-PD-L1 agent or T-cell agonist
  3. Current serious illness or medical condition including, but not limited to uncontrolled active infection
  4. 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
  5. Prior ≥ Grade 3 immune-mediated AEs with anti-PD-1 therapy
  6. History of any grade immune-mediated ocular AEs.
  7. Known hypersensitivity or severe reaction to any component of MCLA-145 or formulation components
  8. 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)
pin location

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.
Phone iconCall +31850162500Email iconEmail Study Center

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

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.