A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
NCT ID: NCT05551117
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2023-06-13
2025-01-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 solid tumors. Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab duocarmazine 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 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT05005728
Vudalimab (XmAb20717) in Combination With Standard of Care Treatment in Patients With Metastatic Castration Sensitive Prostate Cancer
NCT05733351
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
NCT04446117
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT07287150
Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression
NCT02555189
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: MGC018 2.0 mg (Arm A)
MGC018 2.0 mg/kg every 4 weeks
vobramitamab duocarmazine 2.0 mg (Arm A)
2.0 mg/kg intravenous (IV) every 4 weeks
Part 1: MGC018 2.7 mg (Arm B)
MGC018 2.7 mg/kg every 4 weeks
vobramitamab duocarmazine 2.7 mg (Arm B)
2.7 mg.kg IV every 4 weeks
Part 2
MGC018 2.7 mg/kg every 4 weeks
vobramitamab duocarmazine
2.7 mg.kg IV every 4 weeks
Part 1: Control Arm
Patients are administered abiraterone or enzalutamide
Abiraterone
1000 mg once daily
Enzalutamide
160 mg daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
vobramitamab duocarmazine 2.0 mg (Arm A)
2.0 mg/kg intravenous (IV) every 4 weeks
vobramitamab duocarmazine 2.7 mg (Arm B)
2.7 mg.kg IV every 4 weeks
vobramitamab duocarmazine
2.7 mg.kg IV every 4 weeks
Abiraterone
1000 mg once daily
Enzalutamide
160 mg daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous NSCLC, or SCLC.
* Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of \<60 days used as bridging to lutetium-177 is permitted. Up to 3 total prior lines of therapy for mCRPC are permitted..
* Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or metastatic disease.
* All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3 criteria, that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
* All participants must have tumor progression, according to disease-specific criteria, following their most recent anti-cancer therapy.
* All participants must have and available archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
* All participants have acceptable physical condition and laboratory values.
* All participants of childbearing potential must agree to use highly effective methods of birth control.
* All participants must not be pregnant, planning to be pregnant, or breastfeeding.
Exclusion Criteria
* Part 1 only: Received \>1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of \<60 days used as bridging for lutetium-177 is permitted.
* Part 1 only: Received \>3 total prior therapies for mCRPC
* Part 1 only: Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
* Untreated, symptomatic central nervous system (CNS) metastasis.
* Prior treatment with any B7-H3 targeted agent for cancer,
* Contradictions to the use of corticosteroid treatment
* Prior stem cell, tissue, or solid organ transplant.
* Part 1 only: Use of products that have published anti-prostate cancer activity or are known to decrease PSA.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MacroGenics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Liudmila Schafer, M.D.
Role: STUDY_DIRECTOR
MacroGenics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Ghent, , Belgium
Centre Antoine-Lacassagne
Nice, 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
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
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, Île-de-France Region, France
Hopital Foch
Suresnes, Île-de-France Region, 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
Padua, , Italy
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Trento, , Italy
Szpital im. Fryderyka Chopina
Otwock, Masovian Voivodeship, Poland
Magodent Szpital Elblaska
Warsaw, Masovian Voivodeship, Poland
Medical Concierge Centrum Medyczne
Warsaw, Masovian Voivodeship, Poland
Grochowski Hospital
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewodzki im. Mikolaja Kopernika
Koszalin, West Pomeranian Voivodeship, Poland
Przychodnia Lekarska "KOMED"
Konin, WLKP, Poland
Kyungpook National University Chilgok Hospital
Bugok, Daegu, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Hopital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Samsung Meical Cemter
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario Virgen del Rocio
Seville, Seville, Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Institut Catala d'Oncologia Hospitalet
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP-MGC018-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.