A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · May 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-78278343 for men with advanced prostate cancer that has spread to other parts of the body. The main goal of the study is to find the safest dose of this treatment and see how well it works. To be eligible to participate, men must have been diagnosed with prostate cancer that has spread, have already received at least one other treatment, and meet certain health criteria, such as having a good performance status (meaning they can carry out daily activities without much difficulty).

Participants in the trial will receive the study drug and will be monitored closely for side effects and effectiveness. It’s important to note that participants cannot be on any other cancer treatments for at least two weeks before starting this trial, and certain health conditions, like active infections or serious heart problems, may prevent someone from joining. This trial is currently recruiting participants, so if you're interested or want to learn more, it’s a good idea to talk to your doctor.

Gender

MALE

Eligibility criteria

• 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