- Recruiting
- Treatment
- Interventional
- Drug
- PHASE1
- Janssen Research & Development, LLC
- 18 Years -
Study Purpose
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).
Intervention
Drug : JNJ-78278343
Eligibility Requirements
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
Minimum age: 18
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
Recruiting status
Recruiting
Estimated enrollment
260
Study start date
Jul 13, 2021
Study end date
Feb 16, 2026
Last updated
Mar 22, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
PHASE1
Allocation
Na
Sponsor:
Janssen Research & Development, LLC
Collaborator:
N/A
Investigator:
Janssen Research & Development, LLC Clinical Trial
Publications
N/A
Websites
N/A
NCT04898634
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