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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests JNJ-98768111 in people with advanced prostate cancer that has spread to other parts of the body. Part 1 checks its safety and finds the best dose and dosing schedule. Part 2 checks safety at the chosen dose and schedule.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a cancer of gland cells, confirmed by a tissue test. Cancer with small cell or neuroendocrine features is allowed.
  • Have cancer that has spread and can be checked with a CT, MRI, or bone scan. It must have worsened after your most recent treatment, based on PSA blood tests or scans.
  • Have had at least one newer treatment that blocks androgen receptors, which help cancer cells respond to male hormones.
  • Have a PSA blood test level of at least 2 ng/mL. PSA is a protein made by the prostate.
  • Have had surgery to remove the testicles or treatment to lower testosterone. Without that surgery, you must take and continue the required hormone-lowering medicine. Your testosterone must meet the study’s very low level before treatment.
  • Be fully active or able to do light work, even if you cannot do hard physical activity.
  • During the study and for 6 months after the last dose, use highly effective birth control and condoms when semen could pass to another person. Do not donate or freeze sperm for having children, or plan to father a child.
  • Sign a consent form showing that you understand the study and agree to take part.

Who can't join

  • Have active cancer involvement in the brain or spinal cord.
  • Have side effects from past cancer treatment that have not returned to mild levels or your usual level.
  • Had radiation from a machine outside the body to tumors in soft tissue within 14 days before starting study treatment.
  • Had significant heart or blood vessel disease within 6 months before signing the consent form.
  • Have had a solid organ or bone marrow transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (3)

FL

MI

UT