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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04868877

Run by

Merus B.V.

People needed

194

Starts

2021-04-28

Expected to finish

2027-03-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• 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
• University of California, Irvine — Orange, California, United States

Full record on ClinicalTrials.gov

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