Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination

Part of paid clinical trials in Orange, California.

Sponsor
Merus B.V.
Study ID
NCT04868877
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MCLA-129 — DRUG
    full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
  • Osimertinib — DRUG
    Approved, 3rd-generation EGFR-TKI
  • Chemotherapy — DRUG
    administrated by IV infusion

Study Details

A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.

Key Dates

Start date
Apr 28, 2021
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
194 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 2 NSCLC Second-line or more harboring EGFR exon 20 Insertion
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
  • Experimental: Part 2 NSCLC Second-line or more harboring cMet exon 14 skipping mutation
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
  • Experimental: Part 2 Selected solid tumors with or without an EGFR or cMet alteration
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
  • Experimental: Part 2 NSCLC First-line harboring EGFR sensitizing mutations
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
  • Experimental: Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib)
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
  • Experimental: Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy)
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance.
  • Experimental: Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy)
    Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance.

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) [ Time Frame: First 28 days of treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, IrvineOrangeCalifornia92868-
Sarah Cannon Research InstituteNashvilleTennessee37203-
START Mountain RegionWest Valley CityUtah84119-
Next Oncology VirginiaFairfaxVirginia22031-

Find similar trials in Orange, CA

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By specialty
OncologyGI oncologyENT
By research site
University of California, Irvine· Orange, CASarah Cannon Research Institute· Nashville, TNSTART Mountain Region· West Valley City, UTNext Oncology Virginia· Fairfax, VA

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