A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies
NCT ID: NCT03922204
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2019-05-08
2024-11-07
Brief Summary
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Detailed Description
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Part 2 is a dose expansion to confirm the dose of MCLA-145, alone or in combination 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 for patients treated Q2W and 21 days for patients treated Q3W); Safety Follow-up (30 and 90 days after the last dose) including survival follow-up checks every 2 months up to 12 months after the last dose.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MCLA-145
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 (either Q2W for those patients in treatment at the time of Amendment #4 or Q3W with Amendment #4 approval). Treatment will be with MCLA-145 (monotherapy) for Group A, or in combination with pembrolizumab for Group B, 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 either in monotherapy (Group A) or in combination with pembrolizumab (Group B) at the recommended phase II dose every 3 weeks. The duration of each treatment cycle is 21 days
MCLA-145
full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Group B Combination Treatment
Patients in Group B will be treated with MCLA-145 in Combination with pembrolizumab 200mg Q3W.
MCLA-145
full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Pembrolizumab (Keytruda)
Group B patients will be treated in combination with MCLA-145 and pembrolizumab 200mg Q3W.
Interventions
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MCLA-145
full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
Pembrolizumab (Keytruda)
Group B patients will be treated in combination with MCLA-145 and pembrolizumab 200mg Q3W.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Merus N.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Gianluca Laus, MD
Role: STUDY_DIRECTOR
Merus N.V.
Locations
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Moores Cancer Centre
La Jolla, California, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospital Antwerp
Antwerp, Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Netherlands Cancer Institute
Amsterdam, , Netherlands
Hospital Universitario Fundarcion Jimenez Diaz
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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Other Identifiers
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2018-004396-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MCLA-145-CL01/MCLA-145-101
Identifier Type: -
Identifier Source: org_study_id