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
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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)
Locations
United States
California
University of California, Irvine
RECRUITING
Orange
Tennessee
Sarah Cannon Research Institute
COMPLETED
Nashville
Utah
START Mountain Region
COMPLETED
West Valley City
Virginia
Next Oncology Virginia
RECRUITING
Fairfax
Other Locations
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Antwerp University Hospital
COMPLETED
Edegem
France
Clinique de l'Europe
COMPLETED
Amiens
CHU Hopitaux de Bordeaux - Hôpital Saint-André
RECRUITING
Bordeaux
CHU de Lyon - Louis Pradel Hospital
RECRUITING
Bron
Centre Hospitalier Intercommunal de Créteil
RECRUITING
Créteil
Hôpital Albert Calmette
RECRUITING
Lille
L'Institut Paoli - Calmettes
RECRUITING
Marseille
CHU de Nantes - Hôpital Nord Laennec
RECRUITING
Nantes
Hôpital Bichat - Claude-Bernard
RECRUITING
Paris
Hôpital Européen Georges Pompidou (HEGP)
COMPLETED
Paris
Marie Wislez
RECRUITING
Paris
CHU de Poitiers
RECRUITING
Poitiers
Hôpital d'Instruction des Armées Bégin
RECRUITING
Saint-mandé
Germany
Krankenhaus Nordwest
COMPLETED
Frankfurt Am Main
Sana Klinikum Offenbach GmbH
COMPLETED
Offenbach
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
COMPLETED
Bologna
ASST degli Spedali Civili di Brescia
RECRUITING
Brescia
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
COMPLETED
Milan
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
COMPLETED
Orbassano
Istituto Nazionale dei Tumori Regina Elena
RECRUITING
Roma
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
RECRUITING
Salerno
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
COMPLETED
Verona
Netherlands
Netherlands Cancer Institute
RECRUITING
Amsterdam
University Medical Center Groningen
COMPLETED
Groningen
Erasmus Medical Center
RECRUITING
Rotterdam
Republic of Korea
Gachon University Gil Hospital
COMPLETED
Incheon
Samsung Medical Center
COMPLETED
Seoul
Seoul National University Hospital
COMPLETED
Seoul
Severance Hospital - Yonsei Cancer Center
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
COMPLETED
Seoul
The Catholic University of Korea, St. Vincent's Hospital
RECRUITING
Suwon, Gyeonggi-do
Singapore
National Cancer Centre of Singapore
COMPLETED
Singapore
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital HM Delfos
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
IOB Institute of Oncology - Hospital Quironsalud Barcelona
COMPLETED
Barcelona
Centro Integral Oncológico Clara Campal
RECRUITING
Madrid
Clínica Universidad de Navarra -Madrid
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
COMPLETED
Madrid
Hospital Quirón Madrid
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Clínica Universidad de Navarra
RECRUITING
Pamplona
Fundación Instituto Valenciano de Oncología (IVO)
COMPLETED
Valencia
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Contact Information
Primary
Merus Inquiries
USenquiries@merus.nl
617-401-4499
Time Frame
Start Date: 2021-04-28
Estimated Completion Date: 2027-03
Participants
Target number of participants: 576
Treatments
Experimental: 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).
Experimental: 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).
Experimental: 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).
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Merus N.V.