Can a smart drug deliver a toxic payload to prostate cancer cells?
NCT ID NCT07746713
First seen Aug 05, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This early-stage trial is testing an experimental drug called JNJ-98768111 in people with advanced prostate cancer that has spread to other parts of the body. The drug is designed to seek out and attach to a protein called KLK2 on prostate cancer cells, delivering a toxic agent directly to them. The main goals are to assess the drug's safety and find the most suitable dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JNJ-98768111, an antibody-drug conjugate that targets a protein called KLK2 found on prostate cancer cells
- What this could lead to
- If successful, this could lead to a new targeted treatment option for advanced prostate cancer that has spread and stopped responding to current therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not be effective or may cause significant side effects. The results will only show safety and dosing, not whether it works as a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Florida Cancer Specialists & Research Institute
RECRUITINGSarasota, Florida, 34232, United States
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START Mountain Region
RECRUITINGWest Valley City, Utah, 84119, United States
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Start Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can MRI spot which prostate cancers are safe to watch?
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?