New treatment option for advanced prostate cancer using JNJ-98768111

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-phase study tests the investigational drug JNJ-98768111 in men with advanced prostate cancer to determine a safe and potentially effective dose (RP2D) and to assess short-term safety. Part 1 focuses on safety and dose finding, while Part 2 continues safety evaluation at the selected dose in a broader set of participants. Eligibility includes histologically confirmed prostate cancer with measurable disease and prior AR-targeted therapy, along with ongoing testosterone suppression. The study is conducted at multiple sites in the United States and involves continuous androgen deprivation therapy as required by the protocol.

Why it matters

Who can join: the full rules

Inclusion criteria:

* a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy. c. Serum prostate-specific antigen (PSA) value greater than or equal to (\>=) 2 nanograms per milliliters (ng/mL). d. Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of trial drug and must continue this therapy throughout the treatment phase; e. Castrate levels of serum testosterone as defined in the protocol, prior to the first dose of trial intervention; f. Progressive metastatic disease following their most recent line of therapy. Disease progression will be defined by at least one of the following: PSA progression, radiographic progression according to response evaluation criteria in solid tumors (RECIST v1.1), or progressive bone disease according to prostate cancer working group 3 (PCWG3) criteria
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Agree to all of the following during the trial and for 6 months after the last dose of trial drug: a. Use a highly effective method of contraception; b. Wear a condom when engaging in any activity that allows for passage of ejaculate to another person; c. Not to donate sperm or freeze for future use for the purpose of reproduction; d. Not plan to father a child. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception
* Sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the trial and is willing to participate in the trial

Exclusion criteria:

* Active central nervous system (CNS) involvement
* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\<=) 1 or baseline levels
* External beam radiation therapy to soft tissue lesions within 14 days prior to start of trial intervention
* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
* History of solid organ or bone marrow transplantation

Where it's running

• Florida Cancer Specialists & Research Institute
  Sarasota, Florida, United States Recruiting
• Start Midwest
  Grand Rapids, Michigan, United States Recruiting
• Langone Health at NYC University, NYU School of Medicine
  New York, New York, United States Recruiting
• START Mountain Region
  West Valley City, Utah, United States Recruiting
• Rambam Health Care Campus
  Haifa, Israel Recruiting
• Sourasky Medical Center
  Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.