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New dual-action antibody enters early trials for tough-to-treat cancers

NCT ID NCT04868877

Disease control Sponsor: Merus B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests an experimental drug called MCLA-129, a bispecific antibody that targets two cancer-related proteins (EGFR and c-MET). It is for people with advanced non-small cell lung cancer, gastric cancer, esophageal cancer, head and neck cancer, or colorectal cancer that has worsened after standard treatments. The study aims to find the safest dose and check if the drug can shrink tumors, either alone or combined with chemotherapy or other targeted therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

194 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part One: Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens. Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator. * Availability of archival or a fresh tumor tissue sample. * Measurable disease as defined by RECIST version 1.1 by radiologic methods. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 12 weeks, as per Investigator. * Adequate organ function (as per protocol) Exclusion Criteria: * Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (\> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry. * Known leptomeningeal involvement. * Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry. * Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required. * Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible. * Persistent grade \>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed. * History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents. History of hypersensitivity reaction or any toxicity attributed to chemotherapy and components. * History of clinically significant cardiovascular disease * Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD or pneumonitis. * Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug. * Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders * Active Hepatitis B infection without receiving antiviral treatment. * Positive test for Hepatitis C * Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral load are allowed. In

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm esophageal squamous cell carcinoma gastric cancer gastric neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Esophageal squamous cell carcinoma Gastric cancer Head and neck squamous cell carcinoma Non-small cell lung cancer metastatic

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 22162, Italy

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

    Salerno, 84131, Italy

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, 10043, Italy

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • CHU Hopitaux de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000, France

  • CHU de Lyon - Louis Pradel Hospital

    Bron, 69677, France

  • CHU de Nantes - Hôpital Nord Laennec

    Nantes, 44093, France

  • CHU de Poitiers

    Poitiers, 86000, France

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010, France

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050, Spain

  • Clinique de l'Europe

    Amiens, 80090, France

  • Clínica Universidad de Navarra

    Pamplona, 31008, Spain

  • Clínica Universidad de Navarra -Madrid

    Madrid, 28027, Spain

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fundación Instituto Valenciano de Oncología (IVO)

    Valencia, 46009, Spain

  • Gachon University Gil Hospital

    Incheon, 21565, South Korea

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital HM Delfos

    Barcelona, 08023, Spain

  • Hospital Quirón Madrid

    Madrid, 28223, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Hôpital Albert Calmette

    Lille, 59037, France

  • Hôpital Bichat - Claude-Bernard

    Paris, 75877, France

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris, 75908, France

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, 94163, France

  • IOB Institute of Oncology - Hospital Quironsalud Barcelona

    Barcelona, 8023, Spain

  • Institut Jules Bordet

    Anderlecht, Belgium

  • Istituto Nazionale dei Tumori Regina Elena

    Roma, Rome, 00144, Italy

  • Krankenhaus Nordwest

    Frankfurt am Main, Hesse, 60488, Germany

  • L'Institut Paoli - Calmettes

    Marseille, 13009, France

  • Marie Wislez

    Paris, 75014, France

  • National Cancer Centre of Singapore

    Singapore, 169610, Singapore

  • Netherlands Cancer Institute

    Amsterdam, Netherlands

  • Next Oncology Virginia

    Fairfax, Virginia, 22031, United States

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069, Germany

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital - Yonsei Cancer Center

    Seoul, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • University Medical Center Groningen

    Groningen, Netherlands

  • University of California, Irvine

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.