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

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    118
  • sponsor
    Merus N.V.
Updated on 9 June 2022
cancer
lymphoma
metastasis
targeted therapy
mcla-145

Summary

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

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.

Details
Condition Advanced Cancer, Solid Tumor, Adult, B-cell Lymphoma, Adult
Treatment MCLA-145
Clinical Study IdentifierNCT03922204
SponsorMerus N.V.
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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