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

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, tolerabili

Trial Details

NCT ID
NCT03526835
Phase
PHASE1 / PHASE2
Sponsor
Merus B.V.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • MCLA-158
  • MCLA-158 + Pembrolizumab
  • MCLA-158 + FOLFIRI
  • MCLA-158 + FOLFOX
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Diego, California, United States|32.71571,-117.16472
  • Lone Tree, Colorado, United States|39.55171,-104.8863
  • Fort Myers, Florida, United States|26.62168,-81.84059

Key Eligibility Criteria

  • Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy wit…
  • A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe/feasible).
  • Amenable for biopsy (if safe/feasible).
  • Measurable disease as defined by RECIST version 1.1 by radiologic methods.

For full eligibility, visit ClinicalTrials.gov.

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