Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
JNJ-78278343
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed adenocarcinoma of the prostate which has spread to other body parts
Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targetedtherapy or chemotherapy
Measurable or evaluable disease
Concurrent use of any other anticancer treatment must be discontinued for at least 2weeks before the first dose of study drug
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Prior surgical removal of testicles; or, for participants who have not undergonesurgical removal of testicles, must be receiving ongoing androgen deprivationtherapy (ADT) with a gonadotropin releasing hormone analog
Exclusion
Exclusion Criteria:
Disease conditions
Active central nervous system (CNS) involvement
Toxicity related to prior anticancer therapy has not adequately recovered
Prior/Concomitant Therapy
Prior treatment with human kallikrein (KLK) 2-targeted therapy
Received, or are receiving, medications that suppress the immune system within 3days prior to the first dose of study drug
Received or plans to receive any live, attenuated vaccine within 4 weeks prior tothe first dose of study drug
Prior/Concurrent Medical Conditions
Diagnosis of cancer other than prostate cancer within 2 years prior to the firstdose of study drug
Solid organ or bone marrow transplantation
Major clotting diseases within one month prior to the first dose of study drug
Active autoimmune disease within 12 months prior to the first dose of study drug
Active infection
Major diseases of heart and blood vessels within 6 months prior to the first dose ofstudy drug
Clinically significant lung diseases
Active or chronic hepatitis B or hepatitis C infection
Known positive test result for human immunodeficiency virus (unless stable onantiretroviral therapy with undetectable viral load)
Any serious underlying medical conditions or other issue that would impair theability of the participant to receive or tolerate the planned treatment
Study Design
Connect with a study center
Peking University Third Hospital
Beijing, 100191
ChinaActive - Recruiting
Chongqing University Cancer Hospital
Chongqing, 400030
ChinaActive - Recruiting
Sun Yat Sen University Cancer Center
Guang Zhou Shi, 510710
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Center
Guang Zhou Shi, 510710
ChinaActive - Recruiting
First Affiliated Hospital Of Wenzhou Medical College
Wen Zhou Shi, 325399
ChinaActive - Recruiting
Centre Leon Berard
Lyon Cedex 8, 69373
FranceActive - Recruiting
Centre Leon Bérard
Lyon Cedex 8, 69373
FranceActive - Recruiting
APHM Hopital Timone
Marseille, 13005
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94800
FranceActive - Recruiting
National Cancer Center Hospital East
Kashiwa, 277 8577
JapanActive - Recruiting
Yokohama City University Medical Center
Yokohama, 232 0024
JapanActive - Recruiting
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
NetherlandsCompleted
NKI AVL Amsterdam
Amsterdam, 1066 CX
NetherlandsCompleted
NKI-AVL, Amsterdam
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
Erasmus MC
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp Univ Hm Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp. Univ. Hm Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hosp Virgen de La Victoria
Málaga, 29010
SpainActive - Recruiting
Hosp. Virgen de La Victoria
Málaga, 29010
SpainActive - Recruiting
Columbia University Medical Center Herbert Irving Pavilion
New York, New York 10032
United StatesActive - Recruiting
Columbia University Medical Center, Herbert Irving Pavilion
New York, New York 10032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
University of Washington
Seattle, Washington 98195-9472
United StatesActive - Recruiting
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