Prostate Cancer Clinical Trial

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

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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).

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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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT05441501

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There are 6 Locations for this study

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University Of Minnesota
Minneapolis Minnesota, 55455, United States
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia Pennsylvania, 19107, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
University College London Hospitals NHSFT
London , NW1 2, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester , M20 4, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom
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How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT05441501

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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