A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer

A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).

Inclusion Criteria:

• Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
• Measurable or evaluable disease
• At least 1 prior treatment for mCRPC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ functions as defined by certain laboratory values
• Must sign an informed consent form (ICF)
• Participants must agree to use a highly effective form of birth control as guided by the study doctor

Exclusion Criteria:

• Concurrent anticancer therapy
• Severe or long-lasting side effects related to prior anticancer therapy
• Known allergies to JNJ-80038114 or its excipients
• Brain metastasis or known seizure history
• Significant infections or lung, heart or other medical conditions