🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in the Netherlands / NCT04868877
Active, not recruiting Phase 1/2

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

NCT04868877 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Phase
Phase 1/2
Started
2021-04-28
Last updated
2026-02-19

Condition(s) studied

Non-Small Cell Lung Cancer MetastaticGastric CancerEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaColorectal Cancer

Investigational drug(s) / intervention(s)

MCLA-129 →Osimertinib →Chemotherapy

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
University of California, Irvine Orange California
Sarah Cannon Research Institute Nashville Tennessee
START Mountain Region West Valley City Utah
Next Oncology Virginia Fairfax Virginia
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
Sana Klinikum Offenbach GmbH Offenbach Germany
Istituto Nazionale dei Tumori Regina Elena Roma Rome
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

+ 11 more sites — see the full list on the official registry below.

On this site

📄 Tagrisso (osimertinib) drug profile →

More Merus B.V. trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04868877 on ClinicalTrials.gov ↗ ← All trials in the Netherlands