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

Running, not enrolling · Phase 1

Conditions studied: Prostatic Neoplasms

In brief

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).

Key facts

Study ID

NCT04898634

Run by

Janssen Research & Development, LLC

People needed

216

Starts

2021-07-13

Expected to finish

2027-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center Herbert Irving Pavilion — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Washington — Seattle, Washington, United States
• 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

Full record on ClinicalTrials.gov

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