Clinical trial • Phase I • Oncology

Girentuximab labelled with astatine-211 ([211At]) for Non-muscle invasive bladder cancer (refractory)

Phase I trial of Girentuximab labelled with astatine-211 ([211At]) for Non-muscle invasive bladder cancer (refractory). 24 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-muscle invasive bladder cancer (refractory)
Trial Stage
Phase I
Drug Modality
Monoclonal antibody | Radiopharmaceutical

Key dates

Initial CTIS Submission Date
18-08-2025
First CTIS Authorization Date
26-11-2025

Trial design

Phase I trial across 1 site in France.

Target Sample Size
24

Recruitment

Planned Sample Size
24
Recruitment Window Months
48

Geography

Total Number Of Sites
1
Total Number Of Participants
24

France

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
40
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Nuclear Medicine
Principal Investigator Name
Caroline ROUSSEAU
Principal Investigator Email
caroline.rousseau@ico.unicancer.fr
Contact Person Name
Caroline ROUSSEAU
Number Of Participants
24

Sponsor

Primary sponsor

Full Name
Institut De Cancerologie De L Ouest
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
[211At]At-Girentuximab (ATO-101™)
Active Substance
Girentuximab labelled with astatine-211 ([211At])
Modality
Monoclonal antibody | Radiopharmaceutical
First In Human
Yes

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