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
NCT ID: NCT04868877
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
576 participants
INTERVENTIONAL
2021-04-28
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT04222972
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
NCT01519804
Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study
NCT03381274
A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer
NCT01496742
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
NCT04262856
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 2 NSCLC Second-line or more harboring EGFR exon 20 Insertion
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Part 2 NSCLC Second-line or more harboring cMet exon 14 skipping mutation
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Part 2 Selected solid tumors with or without an EGFR or cMet alteration
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Part 2 NSCLC First-line harboring EGFR sensitizing mutations
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Osimertinib
Approved, 3rd-generation EGFR-TKI
Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib)
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Osimertinib
Approved, 3rd-generation EGFR-TKI
Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy)
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance.
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Chemotherapy
administrated by IV infusion
Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy)
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance.
MCLA-129
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Chemotherapy
administrated by IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merus N.V.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Misako Nagasaka, MD
Role: primary
Alex Spira, MD, PhD.
Role: primary
Mariana Brandão, MD, PhD
Role: primary
Amaury Daste, MD
Role: primary
Michael Duruisseaux, MD
Role: primary
Isabelle Monnet, MD
Role: primary
Alexis Cortot, MD
Role: primary
Cecile Vicier, MD, PhD
Role: primary
Stephanie Bordenave, MD
Role: primary
Marie Wislez, MD
Role: primary
Gerard Zalcman, MD, PhD
Role: primary
Nicolas Isambert, MD
Role: primary
Carole Helissey, MD
Role: primary
Federico Capuzzo, MD
Role: primary
Paolo Bossi, MD
Role: primary
Salvatore Siena, MD
Role: primary
Stefano Pepe, MD, PhD.
Role: primary
Gerrina Ruiter, MD
Role: primary
Anne-Marie Dingemans, MD, PhD.
Role: primary
Hye Ryun Kim, MD
Role: primary
Byoung-Yong Shim, MD, PhD.
Role: primary
Tatiana Hernandez Guerrero, MD
Role: primary
Georgia Anguera Palacios, MD
Role: primary
Enriqueta Felip, MD, PhD
Role: primary
Miguel Fernandez de Sanmamed Gutiérrez, MD, PhD
Role: primary
Victor Moreno Garcia, MD, PhD
Role: primary
Luis Paz-Ares Rodriguez, MD, PhD
Role: primary
Irene Moreno Candilejo, MD
Role: primary
Valentina Boni, MD, PhD
Role: primary
Miguel Fernandez de Sanmamed Gutiérrez, MD, PhD
Role: primary
Oscar Jose Juan Vidal, MD, PhD.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCLA-129-CL01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.