Phase
Condition
Carcinoma
Malignant Melanoma
Rectal Cancer
Treatment
Abiraterone
Enzalutamide
vobramitamab duocarmazine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1 only: Histologically confirmed adenocarcinoma of the prostate withoutevidence of neuroendocrine differentiation, signet cell, or small cell features.
Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamousNSCLC, or SCLC.
Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic,castration-sensitive or castration-resistant prostate cancer. A second ARAT regimenof <60 days used as bridging to lutetium-177 is permitted. Up to 3 total prior linesof therapy for mCRPC are permitted..
Part 2 only: At least 1 prior line of systemic therapy for unresectable ormetastatic 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 inhibitorfor advanced or metastatic disease.
All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3criteria, 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-specificcriteria, following their most recent anti-cancer therapy.
All participants must have and available archival or formalin-fixedparaffin-embedded (FFPE) tumor tissue sample for participants with metastasis tointernal organs
All participants have acceptable physical condition and laboratory values.
All participants of childbearing potential must agree to use highly effectivemethods of birth control.
All participants must not be pregnant, planning to be pregnant, or breastfeeding.
Exclusion
Exclusion Criteria:
Any underlying medical or psychiatric condition impairing participant's ability toreceive, tolerate, or comply with the planned treatment or study procedures.
Part 1 only: Received >1 prior taxane-containing regimen for prostate cancer. Asecond 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) arenot eligible unless they received prior treatment with a PARP inhibitor whereavailable, indicated and tolerated.
Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, lastdose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years fromfirst dose of study treatment. Participants who had curative therapy fornon-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 orare known to decrease PSA.
Study Design
Connect with a study center
Ramsay Health Care - Westmead Private Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Cabrini Health- Malvern
Malvern, Victoria 3144
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussles 1200
BelgiumSite Not Available
(Grand Hopital de Charleroi) GHDC
Charleroi, Hainaut 6000
BelgiumSite Not Available
Centre Hospitalier de Ardenne - Libramont - Clinique du Sein
Libramont, Luxembourg 6800
BelgiumSite Not Available
Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)
Godinne, Namur 5300
BelgiumSite Not Available
Algemeen Ziekenhuis Maria Middelares
Gent, 9000
BelgiumSite Not Available
Centre Antoine-Lacassagne
Nice Cedex 2, AM 06189
FranceSite Not Available
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, Bas Rhin 67200
FranceSite Not Available
Institut Bergonié
Bordeaux, Gironde 33076
FranceSite Not Available
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier, Herault 34298
FranceSite Not Available
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, Ile De France 94160
FranceSite Not Available
Hopital Foch
Suresnes, Ile De France 92150
FranceSite Not Available
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, Ille Et Vilaine 35760
FranceSite Not Available
Clinique Victor Hugo
Le Mans, Sarthe 72000
FranceSite Not Available
Gustave Roussy
Villejuif, Val De Marne 94800
FranceSite Not Available
CHRU Brest
Brest, 29200
FranceSite Not Available
Institut Mutualiste Montsouris
Paris, 75014
FranceSite Not Available
AOU San Luigi Gonzaga Oncology Department
Orbassano, TO 10049
ItalySite Not Available
Ospedale dell'Angelo
Mestre, Venice 30174
ItalySite Not Available
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence
Florence, 50134
ItalySite Not Available
Istituto Oncologico Veneto
Padova, 35128
ItalySite Not Available
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Trento, 38122
ItalySite Not Available
Kyungpook National University Chilgok Hospital
Bugok, Daegu 41404
Korea, Republic ofSite Not Available
National Cancer Center
Goyang, Kyonggi 10408
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 5505
Korea, Republic ofSite Not Available
Ewha Womans University Mokdong Hospital
Seoul, 07985
Korea, Republic ofSite Not Available
Samsung Meical Cemter
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hopital
Seoul, 03080
Korea, Republic ofSite Not Available
Yonsei University Health System, Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
Szpital im. Fryderyka Chopina
Otwock, Mazowieckie 05-400
PolandSite Not Available
Grochowski Hospital
Warszawa, Mazowieckie 04-073
PolandSite Not Available
Magodent Szpital Elblaska
Warszawa, Mazowieckie 01-748
PolandSite Not Available
Medical Concierge Centrum Medyczne
Warszawa, Mazowieckie 02-798
PolandSite Not Available
Przychodnia Lekarska "KOMED"
Konin, Wlkp 62-500
PolandSite Not Available
Szpital Wojewodzki im. Mikolaja Kopernika
Koszalin, Zachodniopomorskie 75-581
PolandSite Not Available
Hospital Universitari Parc Taulí
Sabadell, Barcelona 08208
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, Seville 41013
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Del Mar
Barcelona, 08003
SpainSite Not Available
Hospital de la Santa Creu I Sant Pau
Barcelona, 08036
SpainSite Not Available
Institut Catala d'Oncologia Hospitalet
Barcelona, 08036
SpainSite Not Available
Hospital Universitario Lucus Augusti
Lugo, 27002
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
The Royal Marsden NHS Trust
Sutton, Surrey SM2 5PT
United KingdomSite Not Available
Oxford University Hospitals NHS- Churchill Hospital
Oxford, OX3 7LE
United KingdomSite Not Available
Compassionate Cancer Care Medical Group
Fountain Valley, California 92708
United StatesSite Not Available
University of California Los Angeles (UCLA) Community Cancer Care
Los Angeles, California 90095
United StatesSite Not Available
The University of Florida Health System - UF Health Urology - Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United StatesSite Not Available
Pontchartrain Cancer Center
Covington, Louisiana 70433
United StatesSite Not Available
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center
Detroit, Michigan 48201
United StatesSite Not Available
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Gabrail Cancer Center
Canton, Ohio 44718
United StatesSite Not Available
VA Portland Health Care Services
Portland, Oregon 97239
United StatesSite Not Available
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22908
United StatesSite Not Available
Virginia Cancer Specalists
Fairfax, Virginia 22031
United StatesSite Not Available
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesSite Not Available
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