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

NCT07319871 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 78278343PBPCR1005
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs) by Severity

  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.

  Up to 1 year 2 months

• Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)

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

  Up To Day 22

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Up to 1 year 2 months

• Prostate-Specific Antigen (PSA) Response Rate

  Up to 1 year 2 months

• Duration of Response (DOR)

  Up to 1 year 2 months

• Radiographic Progression-Free Survival (rPFS)

  Up to 1 year 2 months

• Time to Response (TTR)

  Up to 1 year 2 months

Study Arms (2)

Part 1: Dose Finding

EXPERIMENTAL

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

Drug: Pasritamig; Drug: JNJ-86974680

Part 2: Dose Expansion

EXPERIMENTAL

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.

Drug: Pasritamig; Drug: JNJ-86974680

Interventions

Pasritamig DRUG

Pasritamig will be administered intravenously.

Also known as: JNJ-78278343

Part 1: Dose Finding; Part 2: Dose Expansion

JNJ-86974680 DRUG

JNJ-86974680 will be administered orally.

Part 1: Dose Finding; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); US (3)