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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

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorMerus B.V.
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 576 to confirmed 194 · Site details revised at 51 of 51 sitesv11 Show 2 more changesShow less
    • Enrollment target: estimated 576 to confirmed 194
    • Site details revised at 51 of 51 sites
  2. Site details revised at 1 of 51 sitesv10
  3. Site contacts updated at 32 of 51 sitesv9
  4. Site contacts updated at 32 of 51 sitesv8
  5. Study sites: 50 to 51v7
Show 5 earlier versionsHide 5 earlier versions
  1. Enrollment target: 380 to 576 Primary completion date: Apr 2024 to Mar 2026 · Primary endpoints revised (2) · Study sites: 53 to 50 · 6 morev6 Show 9 more changesShow less
    • Primary completion date: Apr 2024 to Mar 2026
    • Primary endpoints revised (2)
    • Study sites: 53 to 50
    • Completion date: Apr 2025 to Mar 2027
    • Interventions: MCLA-129 (Drug), Osimertinib (Drug) to Chemotherapy (Drug), MCLA-129 (Drug), Osimertinib (Drug)
    • Eligibility criteria shortened, about 326 words
    • Secondary endpoints: 21 to 9
    • Study title revised
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 25 to 53v5
  3. Study sites: 15 to 25v4
  4. Enrollment target: 150 to 380 Primary endpoints: 1 to 2 · Study sites: 2 to 15 · Interventions: MCLA-129 (Drug) to MCLA-129 (Drug), Osimertinib (Drug) · 3 morev3 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 2 to 15
    • Interventions: MCLA-129 (Drug) to MCLA-129 (Drug), Osimertinib (Drug)
    • Eligibility criteria expanded, about 75 words
    • Secondary endpoints: 19 to 21
    • Study arms: 1 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Start date changed from estimate of Apr 2021 to Apr 28, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merus B.V.
5 trials monitored
See 1 trial at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 3 more diseases
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.
Trial Details
NCT Number NCT04868877
Lead Sponsor Merus B.V.
Conditions Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov