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: Active_not_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
Orange
Tennessee
Sarah Cannon Research Institute
Nashville
Utah
START Mountain Region
West Valley City
Virginia
Next Oncology Virginia
Fairfax
Other Locations
Belgium
Institut Jules Bordet
Anderlecht
Antwerp University Hospital
Edegem
France
Clinique de l'Europe
Amiens
CHU Hopitaux de Bordeaux - Hôpital Saint-André
Bordeaux
CHU de Lyon - Louis Pradel Hospital
Bron
Centre Hospitalier Intercommunal de Créteil
Créteil
Hôpital Albert Calmette
Lille
L'Institut Paoli - Calmettes
Marseille
CHU de Nantes - Hôpital Nord Laennec
Nantes
Hôpital Bichat - Claude-Bernard
Paris
Hôpital Européen Georges Pompidou (HEGP)
Paris
Marie Wislez
Paris
CHU de Poitiers
Poitiers
Hôpital d'Instruction des Armées Bégin
Saint-mandé
Germany
Krankenhaus Nordwest
Frankfurt Am Main
Sana Klinikum Offenbach GmbH
Offenbach
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna
ASST degli Spedali Civili di Brescia
Brescia
ASST Grande Ospedale Metropolitano Niguarda
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano
Istituto Nazionale dei Tumori Regina Elena
Roma
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona
Netherlands
Netherlands Cancer Institute
Amsterdam
University Medical Center Groningen
Groningen
Erasmus Medical Center
Rotterdam
Republic of Korea
Gachon University Gil Hospital
Incheon
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital - Yonsei Cancer Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do
Singapore
National Cancer Centre of Singapore
Singapore
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital HM Delfos
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
IOB Institute of Oncology - Hospital Quironsalud Barcelona
Barcelona
Centro Integral Oncológico Clara Campal
Madrid
Clínica Universidad de Navarra -Madrid
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Quirón Madrid
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Clínica Universidad de Navarra
Pamplona
Fundación Instituto Valenciano de Oncología (IVO)
Valencia
Hospital Universitari i Politècnic La Fe
Valencia
Time Frame
Start Date: 2021-04-28
Completion Date: 2027-03
Participants
Target number of participants: 194
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 B.V.