NCT05441501CompletedPhase 1
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
Source: ClinicalTrials.gov · Last updated 4 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 28 Jun 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 26 Mar 2024
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT05441501
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 15 Nov 2022 to the primary completion date, 26 Mar 2024
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent anticancer therapy
- Severe or long-lasting side effects related to prior anticancer therapy
Other illness
- Known allergies to JNJ-80038114 or its excipients
- Brain metastasis or known seizure history
- Significant infections or lung, heart or other medical conditions
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospitals NHSFT Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust - Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Sidney Kimmel Cancer Center - Jefferson Health Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
Related publications
- A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer.Cancer Chemother Pharmacol · 2026 · PMID 41493473
This page is information, not medical advice. Discuss any trial with your doctor.