A Phase 1 Study of JNJ-80038114 for Advanced Stage Prostate Cancer
Research type
Research Study
Full title
A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
IRAS ID
1005794
Contact name
Andrew Hudson
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-001263-27
ISRCTN Number
ISRCTN16457874
Clinicaltrials.gov Identifier
Research summary
Research Summary:
The purpose of this study is to see if a new study drug can be used in future studies for the treatment of prostate cancer. During the study, side effects caused by
the study drug will be followed closely, as well as how long the study drug stays in the body and how the body responds to it. This is the first time that the study drug
is being tested in humans. It is not approved for use by humans in any country.
Therefore, Part 1 of the study will start with the administration of a low dose of the study drug. After reviewing the results obtained at each dose level, it will be
decided whether or how much to increase the dose for subsequent participants.Lay summary of study results:
No lay summary for this study. The study is out of scope for both CTGOV and EudraCT results submissions.
To meet the UK results submission requirement, you can submit CSR synopsis to the MHRA. The PI's were provided with the CSR synopsis on 04Oct2024. When shared with them, they were reminded of what patients were told in the PIS and they could share this information with them if they were still alive.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0556
Date of REC Opinion
3 Oct 2022
REC opinion
Further Information Favourable Opinion