Prostate Cancer Clinical Trial
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
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).
Eligibility 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
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There are 6 Locations for this study
Minneapolis Minnesota, 55455, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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