Prostate Cancer Clinical Trial
A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
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).
JNJ-78278343 is a humanized immunoglobulin (Ig)G1-based bispecific antibody designed to direct T lymphocytes (T cells) to human kallikrein 2 (hK2or KLK2) positive target tumor cells. One arm of JNJ-78278343 binds to the cluster of differentiation (CD)3 receptor complex present on T cells and the other arm binds to KLK2 present on target tumor cells leading to the activation of the T cells and T-cell-mediated lysis of the KLK2 bearing tumor cells. JNJ-78278343 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). KLK2 expression is highly restricted in normal tissues and highly enriched in prostate adenocarcinoma and its expression is mostly maintained throughout disease progression, making KLK2 an attractive target for therapy. This study will be conducted in 2 phases: a Screening Phase (up to 30 days), a Treatment Phase (start of study drug administration) with an end of treatment (EOT) visit (up to 30 plus 14 days after last dose of study drug or prior to the start of a new anticancer therapy), whichever comes first). The total duration of the study is up to 1 year and 10 months. Safety assessment will include adverse events (AEs) including dose-limiting toxicity (DLT), serious adverse events (SAEs), physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, Eastern Cooperative Oncology Group (ECOG) performance status, and neurologic examination.
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
Active central nervous system (CNS) involvement
Toxicity related to prior anticancer therapy has not adequately recovered
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
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
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There are 11 Locations for this study
New York New York, 10032, United States
New York New York, 10065, United States
Seattle Washington, 98195, United States
Lyon Cedex 8 , 69373, France
Marseille , 13005, France
Villejuif , 94800, France
Amsterdam , 1066 , Netherlands
Rotterdam , 3015 , Netherlands
Madrid , 28040, Spain
Madrid , 28050, Spain
Málaga , 29010, Spain
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