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

NCT03526835

This study is recruiting at 26 US sites in 15 states, according to its ClinicalTrials.gov record last updated .

Summary

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Advanced/Metastatic Solid Tumors
  • Colorectal Cancer
  • Gastric Cancer
  • Gastroesophageal-junction Cancer
  • NSCLC
  • HNSCC
  • Head and Neck Squamous Cell Carcinoma
  • Esophageal Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Merus B.V.
Last updated on ClinicalTrials.gov
July 29, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • UCSD · La Jolla, CA
  • Sharp Healthcare · San Diego, CA

Colorado · 1

  • Rocky Mountain Cancer Centers · Lone Tree, CO

Florida · 2

  • University of Florida · Gainesville, FL
  • Sarah Cannon Research Institute (Lake Nona) · Orlando, FL

Georgia · 1

  • Emory University · Atlanta, GA

Massachusetts · 1

  • Massachusetts General Hospital - Dana Farber · Boston, MA

Missouri · 1

  • Washington University School of Medicine at St Louis · St Louis, MO

New York · 4

  • Cayuga Medical Center · Ithaca, NY
  • Memorial Sloan Kettering Cancer Center · New York, NY
  • Mt. Sinai · New York, NY
  • Hematology-Oncology Associates of Central New York · Syracuse, NY

Ohio · 3

  • Cleveland Clinic · Cleveland, OH
  • Ohio State University · Columbus, OH
  • Taylor Cancer Research Center · Maumee, OH

Oklahoma · 1

  • SSM OKC Hightower Clinical · Oklahoma City, OK

Pennsylvania · 1

  • University of Pennsylvania · Philadelphia, PA

Tennessee · 1

  • The University Of Tennessee Health Science Center · Memphis, TN

Texas · 3

  • Texas Oncology · Dallas, TX
  • Oncology Consultants · Houston, TX
  • Texas Oncology · Tyler, TX

Utah · 2

  • University of Utah Health Huntsman Cancer Hospital · Salt Lake City, UT
  • Utah Cancer Specialists · Salt Lake City, UT

Virginia · 1

  • Oncology & Hematology Associates of Southwest Virginia · Roanoke, VA

Washington · 2

  • Georgetown University Medical Center · Georgetown, WA
  • Cancer Care Northwest · Spokane, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.