A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
Completed · Phase 1
Conditions studied: Prostatic Neoplasms
In brief
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).
Key facts
- Study ID
- NCT05441501
- Run by
- Janssen Research & Development, LLC
- People needed
- 39
- Starts
- 2022-11-15
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2025-03-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Of Minnesota — Minneapolis, Minnesota, United States
- Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- University College London Hospitals NHSFT — London, United Kingdom
- The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom
- Royal Marsden Hospital — Sutton, United Kingdom
Full record on ClinicalTrials.gov
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