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ACTIVE NOT RECRUITING
NCT04868877
PHASE1/PHASE2

Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination

Sponsor: Merus B.V.

View on ClinicalTrials.gov

Summary

A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.

Official title: Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2021-04-28

Completion Date

2027-03

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

DRUG

MCLA-129

full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET

DRUG

Osimertinib

Approved, 3rd-generation EGFR-TKI

DRUG

Chemotherapy

administrated by IV infusion

Locations (51)

University of California, Irvine

Orange, California, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

START Mountain Region

West Valley City, Utah, United States

Next Oncology Virginia

Fairfax, Virginia, United States

Institut Jules Bordet

Anderlecht, Belgium

Antwerp University Hospital

Edegem, Belgium

Clinique de l'Europe

Amiens, France

CHU Hopitaux de Bordeaux - Hôpital Saint-André

Bordeaux, France

CHU de Lyon - Louis Pradel Hospital

Bron, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Hôpital Albert Calmette

Lille, France

L'Institut Paoli - Calmettes

Marseille, France

CHU de Nantes - Hôpital Nord Laennec

Nantes, France

Marie Wislez

Paris, France

Hôpital Bichat - Claude-Bernard

Paris, France

Hôpital Européen Georges Pompidou (HEGP)

Paris, France

CHU de Poitiers

Poitiers, France

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, France

Krankenhaus Nordwest

Frankfurt am Main, Hesse, Germany

Sana Klinikum Offenbach GmbH

Offenbach, Germany

Istituto Nazionale dei Tumori Regina Elena

Roma, Rome, Italy

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

Bologna, Italy

ASST degli Spedali Civili di Brescia

Brescia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Italy

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

Salerno, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Italy

Netherlands Cancer Institute

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

National Cancer Centre of Singapore

Singapore, Singapore

Gachon University Gil Hospital

Incheon, South Korea

Samsung Medical Center

Seoul, South Korea

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, South Korea

Hospital HM Delfos

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

IOB Institute of Oncology - Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Clínica Universidad de Navarra -Madrid

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Centro Integral Oncológico Clara Campal

Madrid, Spain

Hospital Quirón Madrid

Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Spain

Fundación Instituto Valenciano de Oncología (IVO)

Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain