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

• Status: Not yet recruiting
• Trial end date: 2025-03-21
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

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