Spots Global Cancer Trial Database for A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
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Trial Identification
Brief Title: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
Official Title: A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
Study ID: NCT05551117
Conditions
Study Description
Brief Summary: Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic squamous cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC). Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Compassionate Cancer Care Medical Group, Fountain Valley, California, United States
University of California Los Angeles (UCLA) Community Cancer Care, Los Angeles, California, United States
The University of Florida Health System - UF Health Urology - Jacksonville, Jacksonville, Florida, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Pontchartrain Cancer Center, Covington, Louisiana, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center, Detroit, Michigan, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Gabrail Cancer Center, Canton, Ohio, United States
VA Portland Health Care Services, Portland, Oregon, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
University of Virginia Comprehensive Cancer Center, Charlottesville, Virginia, United States
Virginia Cancer Specalists, Fairfax, Virginia, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Ramsay Health Care - Westmead Private Hospital, Westmead, New South Wales, Australia
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH), Woolloongabba, Queensland, Australia
Cabrini Health- Malvern, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, Brussles, Belgium
(Grand Hopital de Charleroi) GHDC, Charleroi, Hainaut, Belgium
Centre Hospitalier de Ardenne - Libramont - Clinique du Sein, Libramont, Luxembourg, Belgium
Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne), Godinne, Namur, Belgium
Algemeen Ziekenhuis Maria Middelares, Gent, , Belgium
Centre Antoine-Lacassagne, Nice Cedex 2, AM, France
Institut de Cancerologie Strasbourg Europe (ICANS), Strasbourg, Bas Rhin, France
Institut Bergonié, Bordeaux, Gironde, France
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle, Montpellier, Herault, France
Hôpital d'Instruction des Armées Bégin, Saint-Mandé, Ile De France, France
Hopital Foch, Suresnes, Ile De France, France
Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire, Ille Et Vilaine, France
Clinique Victor Hugo, Le Mans, Sarthe, France
Gustave Roussy, Villejuif, Val De Marne, France
CHRU Brest, Brest, , France
Institut Mutualiste Montsouris, Paris, , France
AOU San Luigi Gonzaga Oncology Department, Orbassano, TO, Italy
Ospedale dell'Angelo, Mestre, Venice, Italy
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara, Trento, , Italy
Kyungpook National University Chilgok Hospital, Bugok, Daegu, Korea, Republic of
National Cancer Center, Goyang, Kyonggi, Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
Seoul National University Hopital, Seoul, , Korea, Republic of
Yonsei University Health System, Severance Hospital, Seoul, , Korea, Republic of
Samsung Meical Cemter, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Szpital im. Fryderyka Chopina, Otwock, Mazowieckie, Poland
Magodent Szpital Elblaska, Warszawa, Mazowieckie, Poland
Medical Concierge Centrum Medyczne, Warszawa, Mazowieckie, Poland
Grochowski Hospital, Warszawa, Mazowieckie, Poland
Przychodnia Lekarska "KOMED", Konin, Wlkp, Poland
Szpital Wojewodzki im. Mikolaja Kopernika, Koszalin, Zachodniopomorskie, Poland
Hospital Universitari Parc Taulí, Sabadell, Barcelona, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Seville, Spain
Hospital Del Mar, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
The Royal Marsden NHS Trust, Sutton, Surrey, United Kingdom
Oxford University Hospitals NHS- Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Ashley Ward, M.D.
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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