๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-28

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors (NCT03526835)

Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Merus B.V.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UCSD โ€” La Jolla, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (54 Sites)

Showing the first 25 of 54 sites.

  • UCSD โ€” La Jolla, California
  • USC Norris Comprehensive Cancer Center โ€” Los Angeles, California
  • Sharp Healthcare โ€” San Diego, California
  • Rocky Mountain Cancer Centers โ€” Lone Tree, Colorado
  • Florida Cancer Specialists โ€” Fort Myers, Florida
  • University of Florida โ€” Gainesville, Florida
  • Sarah Cannon Research Institute (Lake Nona) โ€” Orlando, Florida
  • Emory University โ€” Atlanta, Georgia
  • Massachusetts General Hospital - Dana Farber โ€” Boston, Massachusetts
  • Karmanos Cancer Institute โ€” Detroit, Michigan
  • SSM Health Saint Louis University Hospital โ€” St Louis, Missouri
  • Washington University School of Medicine at St Louis โ€” St Louis, Missouri
  • Cayuga Medical Center โ€” Ithaca, New York
  • Mt. Sinai โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Hematology-Oncology Associates of Central New York โ€” Syracuse, New York
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Ohio State University โ€” Columbus, Ohio
  • Taylor Cancer Research Center โ€” Maumee, Ohio
  • SSM OKC Hightower Clinical โ€” Oklahoma City, Oklahoma
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • The University Of Tennessee Health Science Center โ€” Memphis, Tennessee
  • Sarah Cannon Research Institute โ€” Nashville, Tennessee
  • Texas Oncology โ€” Dallas, Texas
  • Oncology Consultants โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: +31 85 016 2500

Email: enquiries-merus@genmab.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—