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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) — First 28 days of treatment
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 as well as in combination with chemotherapy in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease. - To evaluate clinical activity, as assessed by ORR — From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate the ORR of MCLA-129 monotherapy or in combination with an EGFR TKI or chemotherapy in molecularly defined populations of advanced/metastatic solid tumors.
Trial sites (51)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 France
Other trials for the same condition
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 France