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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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