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Clinical Trials in the UK / NCT07319871
Recruiting Phase 1

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

NCT07319871 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2026-01-14
Last updated
2026-08-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

PasritamigJNJ-86974680

Pasritamig: Pasritamig will be administered intravenously.

JNJ-86974680: JNJ-86974680 will be administered orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 criteria: * 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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Florida Cancer Specialists Sarasota Florida Recruiting
Columbia University Medical Center New York New York Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
The Christie NHS Foundation Trust Christie Hospital Manchester United Kingdom Recruiting
Royal Marsden Hospital Sutton United Kingdom Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07319871 on ClinicalTrials.gov ↗ ← All trials in the UK