Phase 1b Study of JNJ-78278343 With JNJ-95298177 Given Intravenously for Treating Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and recommended dose of a combination of two investigational drugs, JNJ-78278343 and JNJ-95298177, for treating men with metastatic castration-resistant prostate cancer mCRPC, an advanced stage where the cancer has spread beyond the prostate and is resistant to hormonal therapy. The study aims to identify the best dose for further testing and confirm its safety and anti-tumor activity. Participants will be treated in two parts Part 1 involves a dose de-escalation schedule using the Bayesian Optimal Interval Design to find the recommended phase 2 combination dose RP2CD of the two intravenous drugs. In Part 2, participants will receive the RP2CD to evaluate safety and anti-tumor effects. Both drugs are given intravenously, and the study uses a sequential design to progress from dose confirmation to dose expansion. During the study, participants will be regularly monitored for adverse events, dose-limiting toxicities, prostate-specific antigen PSA response, tumor progression, and drug serum concentrations for up to two years and two months. Assessments include safety evaluations, imaging, laboratory tests, and antibody monitoring. The study lasts up to the completion date in March 2027, with ongoing safety and response monitoring throughout.

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