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 13 Locations for this study
Bethesda Maryland, 20892, United States
Minneapolis Minnesota, 55455, United States
New York New York, 10032, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
Lyon , 69008, France
Marseille , 13005, France
Villejuif , 94800, France
Düsseldorf , 40225, Germany
Freiburg , 79106, Germany
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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