A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new combination of two drugs, JNJ-87189401 and JNJ-78278343, to see how well they work together for men with advanced prostate cancer that has not responded to standard treatments. The study is being conducted in two parts: the first part will find the best doses to use, while the second part will focus on checking how safe these doses are for patients. The trial is currently looking for male participants aged 65 to 74 who have been diagnosed with a specific type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC).

To be eligible for the study, participants need to have cancer that can be measured and must have a certain level of a protein called PSA in their blood. They should also have undergone a procedure to lower testosterone levels or be on medication to do so. However, individuals with certain heart conditions or active autoimmune diseases will not be able to participate. Those who join the trial can expect to receive careful monitoring during treatment and will be contributing to valuable research that could help improve future prostate cancer therapies.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate Cancer Working Group 3 (PCWG3): 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; all participants must have a serum PSA value greater than or equal to (\>=2) nanograms per milliliter (ng/mL) at time of screening
• • 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:
• • Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• • 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