Treatment for advanced prostate cancer using a T-cell redirecting agent
A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
This study is testing a new treatment for advanced prostate cancer to see if a special agent can help patients who have run out of other options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 17 sites (New York, New York and 16 other locations) |
| Trial ID | NCT04898634 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and recommended doses of JNJ-78278343, a T-cell-redirecting agent targeting human kallikrein 2 (KLK2), in patients with advanced prostate cancer. The study is divided into two parts: the first part focuses on dose escalation to determine the optimal dose, while the second part assesses the safety of this dose in a larger group of participants. Eligible patients must have confirmed metastatic castration-resistant prostate cancer and have received prior treatment with specific therapies. The trial aims to provide a new therapeutic option for patients with limited treatment alternatives.
Who should consider this trial
Good fit: Ideal candidates for this study are men with confirmed metastatic castration-resistant prostate cancer who have previously undergone treatment with androgen receptor-targeted therapies or chemotherapy.
Not a fit: Patients with active central nervous system involvement or those who have previously received KLK2-targeted therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel therapeutic option for patients with advanced prostate cancer who have exhausted other treatment options.
How similar studies have performed: While this approach is innovative, similar studies targeting T-cell redirecting agents have shown promise in other cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 16 other locations
- Columbia University Medical Center Herbert Irving Pavilion — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Peking University Third Hospital — Beijing, China (Recruiting)
- Chongqing University Cancer Hospital — Chongqing, China (Recruiting)
- Sun Yat Sen University Cancer Center — Guang Zhou Shi, China (Recruiting)
- First Affiliated Hospital Of Wenzhou Medical College — Wen Zhou Shi, China (Recruiting)
- Centre Leon Berard — Lyon Cedex 8, France (Recruiting)
- APHM Hopital Timone — Marseille, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
- National Cancer Center Hospital East — Kashiwa, Japan (Recruiting)
- Yokohama City University Medical Center — Yokohama, Japan (Recruiting)
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (Completed)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain (Recruiting)
- Hosp Univ Hm Sanchinarro — Madrid, Spain (Recruiting)
- Hosp Virgen de La Victoria — Málaga, Spain (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.