Status:
COMPLETED
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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
- 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
- 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
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05441501
Start Date
November 15 2022
End Date
March 31 2024
Last Update
March 4 2025
Active Locations (6)
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1
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
4
University College London Hospitals NHSFT
London, United Kingdom, NW1 2PG