Combination treatment for advanced prostate cancer
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
This study is testing a combination of two new drugs to see if they are safe and how well they work for people with advanced prostate cancer that hasn't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 355 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 13 sites (Aurora, Colorado and 12 other locations) |
| Trial ID | NCT06095089 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and optimal dosing regimen of two investigational drugs, JNJ-87189401 and JNJ-78278343, in patients with advanced prostate cancer. The trial consists of two parts: the first part focuses on dose escalation to determine the recommended phase 2 regimen, while the second part involves dose expansion to further assess safety. Participants must have metastatic castration-resistant prostate cancer and meet specific eligibility criteria, including prior androgen deprivation therapy.
Who should consider this trial
Good fit: Ideal candidates are men with metastatic castration-resistant prostate cancer who have undergone prior androgen deprivation therapy.
Not a fit: Patients with small cell carcinoma or those who have not received prior androgen deprivation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer.
How similar studies have performed: Other studies have shown promise with similar combination therapies in advanced prostate cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed * Measurable or evaluable disease per PCWG3 criteria * Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * History of an autoimmune disease within the 12 months prior to signing consent * Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Where this trial is running
Aurora, Colorado and 12 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- University Of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- START New Jersey — East Brunswick, New Jersey, United States (Recruiting)
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States (Recruiting)
- Oregon Health And Science University — Portland, Oregon, United States (Recruiting)
- Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States (Recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- South Texas Accelerated Research Therapeutics, LLC (START) — San Antonio, Texas, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
- Institut Bergonie — Bordeaux, France (Recruiting)
- Centre Leon Berard — Lyon, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
- The Cancer Institute Hospital of JFCR — Tokyo, Japan (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.