RecruitingPhase 1NCT07082920

A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

140 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Prostatic Neoplasms

Summary

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two experimental drugs — JNJ-78278343 and JNJ-95298177 — for men with metastatic castration-resistant prostate cancer (mCRPC), which is advanced prostate cancer that continues to grow despite hormone-reducing treatments. **You may be eligible if...** - You have confirmed metastatic castration-resistant prostate cancer - You have had prior hormone-reducing therapy (surgical or medical castration) or are ongoing with it - Your PSA (prostate-specific antigen) level is at least 2 ng/mL - You are in good general health (ECOG 0–1) with measurable or evaluable disease **You may NOT be eligible if...** - You have active brain metastases (certain stable, treated brain metastases may be allowed) - You have received certain prior treatments including T-cell redirecting therapies, immune checkpoint inhibitors within 6 weeks, or specific PSMA-targeted therapies - You have significant unresolved side effects from prior treatment - You are allergic to any components of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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