NCT07164443

A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 663 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Conditions

• Metastatic Castration-resistant Prostate Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Pasritamig	Pasritamig will be administrated through IV infusion.
OTHER	Placebo	Placebo will be administrated through IV infusion.
DRUG	Best Supportive Care (BSC)	BSC will be administered at the discretion of the treating physician.

Timeline

• Start date: 2025-09-02
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2025-09-10
• Last updated: 2026-04-13

Locations

163 sites across 17 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Italy, Japan, Netherlands, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study