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A Study of Pasritamig and JNJ-86974680 for Prostate Cancer

This study is testing two drugs, Pasritamig and JNJ-86974680, in people with advanced prostate cancer. Pasritamig is given through a vein (intravenously), and JNJ-86974680 is taken by mouth. The main goals are to find the best combination dose of these drugs and to see how safe and tolerable that dose is. You may be able to join if you are 18 years or older, of any gender, and have prostate adenocarcinoma. The study is looking for about 40 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects for up to 1 year and 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07319871

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~40 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PasritamigJNJ-86974680

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs) by Severity
Measured over Up to 1 year 2 months
+1 more outcome measured

Conditions

Prostatic Neoplasms

Explore related trials

Prostate CarcinomaKLK3 Gene

Where it's being run

5 sites across 4 states
United Kingdom2
Florida1
New York1
Ohio1

Study leadership

  • Janssen Research & Development, LLC Clinical trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \[e.g.\], immunohistochemistry \[IHC\] with both androgen receptor \[AR\]- and NE-marker positivity) are allowed
Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included
Prior orchiectomy or medical castration (for example, 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)
Prostate-specific antigen (PSA) greater than or equal to (\>=) 2 nanograms per milliliters (ng/mL) at screening
Measurable or evaluable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion

Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, neuropathy \[Grade 2\] and vitiligo)
Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680
Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Antibiotic or antiviral prophylaxis is allowed
Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic \>2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment
Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

What this trial measures

  • Number of Participants With Adverse Events (AEs) by SeverityUp to 1 year 2 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol.

  • Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)Up To Day 22

    High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.