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).

View Eligibility Criteria

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:

110

Study ID:

NCT05441501

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 13 Locations for this study

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Center for Cancer Research National Cancer Institute
Bethesda Maryland, 20892, United States
University Of Minnesota
Minneapolis Minnesota, 55455, United States
Columbia University Medical Center
New York New York, 10032, United States
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia Pennsylvania, 19107, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Centre Leon Bérard
Lyon , 69008, France
CHU de la Timone
Marseille , 13005, France
Gustave Roussy
Villejuif , 94800, France
Universitätsklinikum Düsseldorf
Düsseldorf , 40225, Germany
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT05441501

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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