NCT07746713RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of Part 1 of this study is to find out how safe JNJ-98768111 is and the most suitable dose (recommended phase 2 dose \[RP2D\]) regimen(s) of JNJ-98768111. The purpose of Part 2 of this study is to find out how safe JNJ-98768111 is at the RP2D regimen(s) in participants with advanced prostate cancer (cancer of the prostate, a male reproductive gland found below the bladder, which has spread extensively to other parts of the body).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 31 Jul 2026
- Start date
- 5 Aug 2026
- Primary completion date
- 16 Mar 2029
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT07746713
- EU CT number
- 2026-525894-37-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 5 Aug 2026 to the primary completion date, 16 Mar 2029
- 8 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of solid organ or bone marrow transplantation
Other
- Active central nervous system (CNS) involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Langone Health at NYC University, NYU School of Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Florida Cancer Specialists & Research Institute Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.