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

Recruiting now · Phase 1

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT07319871

Run by

Janssen Research & Development, LLC

People needed

40

Starts

2026-01-14

Expected to finish

2027-04-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom (enrolling)
• Royal Marsden Hospital — Sutton, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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