[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

+31302538800

Email address

enquires@merus.nl

Condition

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

Treatment type

Interventional

Investigational product

MCLA-145

Phase

Phase 1

Sponsor

Merus N.V.

ClinicalTrials.gov identifier

NCT03922204

Study number

MCLA-145-CL01/MCLA-145-101

Understanding clinical trials

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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

  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

  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)

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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