Clinical trial • Phase I • Oncology

THE-0504 for Solid tumors

Phase I trial of THE-0504 for Solid tumors. 30 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid tumors
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
28-05-2024
First CTIS Authorization Date
16-09-2024

Trial design

Phase I trial across 1 site in Italy.

Target Sample Size
30

Eligibility

Recruits 30 Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling provided..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling provided.

Recruitment

Planned Sample Size
30
Recruitment Window Months
30

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Italy

Earliest CTIS Part Ii Submission Date
23-08-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
545
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Fase I
Contact Person Name
Gennaro Daniele

Sponsor

Primary sponsor

Full Name
Thena Biotech S.r.l.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
THE-0504

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