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A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
SponsorMerus B.V.
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 5 months later Nov 2025 → May 2028
Primary endpoints added 6 → 10 primary endpoints
See other at-risk trials from Merus B.V.

Record History

  1. Primary completion pushed from Nov 2025 to May 2028 Primary endpoint(s) modified · Trial sites expanded: 45 → 54 locations · Completion pushed from Nov 2027 to Nov 2028 · 4 morev8 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 45 → 54 locations
    • Completion pushed from Nov 2027 to Nov 2028
    • Enrollment target: 523 to 560
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 24 to 25
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints revised (6) Enrollment target: 567 to 523 · Study sites: 39 to 45 · Interventions: MCLA-158 (Drug), MCLA-158 + FOLFIRI (Combination Product), MCLA-158 + Pembrolizumab (Combination Product) to MCLA-158 (Drug), MCLA-158 + FOLFIRI (Combination Product), MCLA-158 + FOLFOX (Combination Product), MCLA-158 + Pembrolizumab (Combination… · 4 morev7 Show 7 more changesShow less
    • Enrollment target: 567 to 523
    • Study sites: 39 to 45
    • Interventions: MCLA-158 (Drug), MCLA-158 + FOLFIRI (Combination Product), MCLA-158 + Pembrolizumab (Combination Product) to MCLA-158 (Drug), MCLA-158 + FOLFIRI (Combination Product), MCLA-158 + FOLFOX (Combination Product), MCLA-158 + Pembrolizumab (Combination…
    • Eligibility criteria shortened, about 149 words
    • Secondary endpoints: 29 to 24
    • Study description expanded, about 21 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 360 to 567 Primary completion date: Jun 2024 to Nov 2025 · Primary endpoints: 14 to 6 · Completion date: Jun 2025 to Nov 2027 · 6 morev6 Show 9 more changesShow less
    • Primary completion date: Jun 2024 to Nov 2025
    • Primary endpoints: 14 to 6
    • Completion date: Jun 2025 to Nov 2027
    • Interventions: MCLA-158 (Drug), MCLA-158 +Pembrolizumab (Combination Product) to MCLA-158 (Drug), MCLA-158 + FOLFIRI (Combination Product), MCLA-158 + Pembrolizumab (Combination Product)
    • Eligibility criteria expanded, about 138 words
    • Secondary endpoints: 25 to 29
    • Study description expanded, about 94 words
    • Site contacts updated at 37 of 39 sites
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Jun 2023 to Jun 2024 Primary endpoints: 3 to 14 · Study sites: 15 to 39 · Completion date: Jun 2024 to Jun 2025 · 5 morev5 Show 8 more changesShow less
    • Primary endpoints: 3 to 14
    • Study sites: 15 to 39
    • Completion date: Jun 2024 to Jun 2025
    • Interventions: MCLA-158 (Drug) to MCLA-158 (Drug), MCLA-158 +Pembrolizumab (Combination Product)
    • Eligibility criteria expanded, about 285 words
    • Secondary endpoints: 23 to 25
    • Study description shortened, about 59 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Phase 1 to Phase 1/2 Enrollment target: 120 to 360 · Primary completion date: Jan 2021 to Jun 2023 · Primary endpoints: 7 to 3 · 6 morev4 Show 9 more changesShow less
    • Enrollment target: 120 to 360
    • Primary completion date: Jan 2021 to Jun 2023
    • Primary endpoints: 7 to 3
    • Study sites: 4 to 15
    • Completion date: Jan 2021 to Jun 2024
    • Eligibility criteria expanded, about 155 words
    • Secondary endpoints: 18 to 23
    • Study description expanded, about 23 words
    • Collaborators shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 1 of 4 sitesv3
  2. Start date changed from estimate of May 2018 to May 2, 2018 Site details revised at 1 of 4 sitesv2 Show 1 more changeShow less
    • Site details revised at 1 of 4 sites
  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
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
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
and 2 more diseases
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.
Trial Details
NCT Number NCT03526835
Lead Sponsor Merus B.V.
Conditions Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, NSCLC, HNSCC, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer
Enrollment 560 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov