The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)-targeted therapy or chemotherapy
* Measurable or evaluable disease
* Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks 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 undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog
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 3 days prior to the first dose of study drug
* Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug
Prior/Concurrent Medical Conditions
* Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose 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 of study drug
* Clinically significant lung diseases
* Active or chronic hepatitis B or hepatitis C infection
* Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)
* Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment
Primary outcome measure(s)
Part 1 and 2: Number of Participants With Adverse Events (AEs) — Up to 1 year and 10 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Part 1 and 2: Number of Participants With AEs by Severity — Up to 1 year and 10 months Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) — Up to 1 year and 10 months Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Trial sites (17)
Facility
City
Region
Status
Columbia University Medical Center Herbert Irving Pavilion
New York
New York
Memorial Sloan Kettering Cancer Center
New York
New York
University of Washington
Seattle
Washington
Peking University Third Hospital
Beijing
China
Chongqing University Cancer Hospital
Chongqing
China
Sun Yat Sen University Cancer Center
Guangzhou
China
First Affiliated Hospital Of Wenzhou Medical College
Wenzhou
China
Centre Leon Berard
Lyon
France
APHM Hopital Timone
Marseille
France
Institut Gustave Roussy
Villejuif
France
National Cancer Center Hospital East
Kashiwa
Japan
Yokohama City University Medical Center
Yokohama
Japan
Antoni van Leeuwenhoek
Amsterdam
Netherlands
Erasmus MC
Rotterdam
Netherlands
Hosp Univ Fund Jimenez Diaz
Madrid
Spain
Hosp Univ Hm Sanchinarro
Madrid
Spain
Hosp Virgen de La Victoria
Málaga
Spain
More Janssen Research & Development, LLC trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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