Clinical trial • Phase I • Oncology

AROG4-01 for Advanced refractory solid tumors

Phase I trial of AROG4-01 for Advanced refractory solid tumors. 40 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced refractory solid tumors
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
15-01-2025
First CTIS Authorization Date
11-04-2025

Trial design

Phase I trial across 3 sites in Spain.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
40

Eligibility

Recruits 40 No vulnerable population selected; consent/assent details not provided..

Vulnerable Population
No vulnerable population selected; consent/assent details not provided.

Recruitment

Planned Sample Size
40
Recruitment Window Months
24

Geography

Total Number Of Sites
3
Total Number Of Participants
40

Spain

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
06-05-2025
Processing Time Days
50
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Maria Jové Casulleras
Contact Person Email
mjove@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Víctor Moreno García
Contact Person Email
victor.moreno@startmadrid.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Cinta Hierro Carbó
Contact Person Email
chierro@iconcologia.net

Sponsor

Primary sponsor

Full Name
Applied Research Using Omic Sciences S.L.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
AROG4-01
Routes Of Administration
Intravenous
Route
Intravenous
First In Human
Yes

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