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Taking people in United StatesPhase 1

Pasritamig with JNJ-86974680 for advanced prostate cancer

Tests pasritamig with JNJ-86974680 in adults with advanced prostate cancer.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Cleveland, New York, and Sarasota, United StatesSee the 3 sitesAlso in 1 other country, 2 sites
Trial code
Registry title
A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer
Status
Recruiting
Phase
Phase 1
People taking part
40 people, planned
Started
14 Jan 2026
Expected to end
15 Mar 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Pasritamig
  • JNJ-86974680
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced prostate cancer that has stopped responding to hormone-lowering treatment and has spread to bone or lymph nodes.

Age
18 years or older
Sex
All sexes
Disease stage
Prostate adenocarcinoma that has spread (metastatic) and is castration-resistant (mCRPC). It has spread to bone, lymph nodes, or both, with no clear spread to organs such as the liver or lungs. Measurable or evaluable disease is needed.
Earlier treatment
Prior removal of the testicles (orchiectomy) or ongoing medical castration with a GnRH analog (agonist or antagonist), which must continue during the trial.
Biomarker or test result
PSA of 2 ng/mL or higher at screening. ECOG performance status of 0 or 1.

Main reasons for not taking part

  • Small cell, carcinoid, or neuroendocrine prostate cancer (adenocarcinoma with neuroendocrine features is allowed)
  • Side effects from earlier cancer treatment that have not improved to grade 1 or baseline
  • Known allergy to any component of pasritamig or JNJ-86974680
  • Active infection needing antibiotics in the 7 days before the first dose
  • Brain metastases or leptomeningeal disease, unless treated, stable, and symptom-free for over 2 weeks and off corticosteroids for at least 2 weeks

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680
  • 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

Where in United States

Also in 1 other country, 2 sites

  • University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
  • Columbia University Medical CenterNew York, United StatesTaking people
  • Florida Cancer SpecialistsSarasota, United StatesTaking people

About the trial

What the trial wants to find out

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.

The 2 groups in the trial

  • Part 1: Dose FindingTreatment being tested

    Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen.

    Treatment: Pasritamig and JNJ-86974680

  • Part 2: Dose ExpansionTreatment being tested

    Participants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity.

    Treatment: Pasritamig and JNJ-86974680

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer
Plain-language title
Pasritamig with JNJ-86974680 for advanced prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
3 November 2026