Clinical trial • Phase I • Oncology

JNJ-87704916 for Advanced solid tumors

Phase I trial of JNJ-87704916 for Advanced solid tumors. 58 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors
Trial Stage
Phase I
Drug Modality
Gene therapy

Key dates

Initial CTIS Submission Date
24-11-2023
First CTIS Authorization Date
25-03-2024

Trial design

Phase I trial across 4 sites in Spain, France.

Target Sample Size
58

Eligibility

Recruits 58 Vulnerable population not selected; no consent or assent handling described in the available record..

Vulnerable Population
Vulnerable population not selected; no consent or assent handling described in the available record.

Recruitment

Planned Sample Size
58
Recruitment Window Months
97

Geography

Total Number Of Sites
4
Total Number Of Participants
38

Spain

Earliest CTIS Part Ii Submission Date
13-12-2023
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
804
Number Of Sites
3
Number Of Participants
19

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Enriqueta Felip
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Medical Oncology
Principal Investigator Name
Emiliano Calvo
Principal Investigator Email
emiliano.calvo@startmadrid.com
Contact Person Name
Emiliano Calvo
Contact Person Email
emiliano.calvo@startmadrid.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Principal Investigator Name
Victor Moreno
Principal Investigator Email
victor.moreno@startmadrid.com
Contact Person Name
Victor Moreno
Contact Person Email
victor.moreno@startmadrid.com

France

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
773
Number Of Sites
1
Number Of Participants
19

Sites

Site Name
Institut Gustave Roussy
Department Name
DITEP
Principal Investigator Name
Rastilav BAHLEDA
Principal Investigator Email
Rastilav.BAHLEDA@gustaveroussy.fr
Contact Person Name
Rastilav BAHLEDA

Sponsor

Primary sponsor

Full Name
Johnson And Johnson Enterprise Innovation Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
JNJ-87704916
Modality
Gene therapy
Routes Of Administration
Intratumoural injection
Route
Intratumoural
Authorisation Status
Investigational

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