Status:
RECRUITING
A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2027
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04898634
Start Date
July 13 2021
End Date
February 10 2027
Last Update
December 11 2025
Active Locations (17)
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1
Columbia University Medical Center Herbert Irving Pavilion
New York, New York, United States, 10032
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
University of Washington
Seattle, Washington, United States, 98195-9472
4
Peking University Third Hospital
Beijing, China, 100191