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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjenci z potwierdzonym, zaawansowanym nowotworem, którego nie można leczyć standardowymi metodami.
  • Dostępna próbka guza (jeśli bezpieczne i możliwe).
  • Pacjent musi wyrazić zgodę na pobranie próbki guza (biopsję), jeśli jest to bezpieczne i możliwe.
  • Choroba widoczna w badaniach obrazowych.
  • Ogólny stan zdrowia pozwalający na udział w badaniu.
  • Przewidywany czas życia co najmniej 12 tygodni.
  • Prawidłowa funkcja serca.
  • Dobra ogólna czynność narządów.

✗ Disqualifies

  • Pacjenci, którzy wcześniej nie byli leczeni określonymi terapiami (zależnie od grupy badanej).
  • Pacjenci z pewnymi zmianami genetycznymi w guzie (zależnie od grupy badanej).
  • Pacjenci z określonym typem niestabilności mikrosatelitarnej guza (zależnie od grupy badanej).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (54)

UCSD

La Jolla, United States

USC Norris Comprehensive Cancer Center

Los Angeles, United States

Sharp Healthcare

San Diego, United States

Rocky Mountain Cancer Centers

Lone Tree, United States

Florida Cancer Specialists

Fort Myers, United States

University of Florida

Gainesville, United States

Sarah Cannon Research Institute (Lake Nona)

Orlando, United States

Emory University

Atlanta, United States

Massachusetts General Hospital - Dana Farber

Boston, United States

Karmanos Cancer Institute

Detroit, United States

SSM Health Saint Louis University Hospital

St Louis, United States

Washington University School of Medicine at St Louis

St Louis, United States

Cayuga Medical Center

Ithaca, United States

Mt. Sinai

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Hematology-Oncology Associates of Central New York

Syracuse, United States

Cleveland Clinic

Cleveland, United States

Ohio State University

Columbus, United States

Taylor Cancer Research Center

Maumee, United States

SSM OKC Hightower Clinical

Oklahoma City, United States

University of Pennsylvania

Philadelphia, United States

The University Of Tennessee Health Science Center

Memphis, United States

Sarah Cannon Research Institute

Nashville, United States

Texas Oncology

Dallas, United States

Oncology Consultants

Houston, United States

Texas Oncology

Tyler, United States

Utah Cancer Specialists

Salt Lake City, United States

University of Utah Health Huntsman Cancer Hospital

Salt Lake City, United States

Oncology & Hematology Associates of Southwest Virginia

Roanoke, United States

Georgetown University Medical Center

Georgetown, United States

Cancer Care Northwest

Spokane, United States

Cliniques universitaires Saint-Luc

Brussels, Belgium

Institut Jules Bordet

Brussels, Belgium

UZ Gent

Ghent, Belgium

Chu Ucl Namur Site De Sainte-Elisabeth

Namur, Belgium

Hopital Saint Andre, CHU Bordeaux

Bordeaux, France

Centre Leon Berard

Lyon, France

Hopital La Timone

Marseille, France

Institut Régional du Cancer de Montpellier

Montpellier, France

Centre Antoine Lacassagne

Nice, France

Institut Curie

Paris, France

Institut Gustave Roussy

Paris, France

Centre Henri Becquerel

Rouen, France

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

NKI - Antoni van Leeuwenhoek

Amsterdam, Netherlands

UMC Radboud

Nijmegen, Netherlands

UMC Utrecht

Utrecht, Netherlands

Vall d'Hebron

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.

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