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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.
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
Conditions
Interventions
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Osimertinib
Approved, 3rd-generation EGFR-TKI
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