Clinical trial • Phase I • Oncology

[64Cu]Cu-PSMA-R2 for Metastatic prostate cancer|Adenocarcinoma of prostate

Phase I trial of [64Cu]Cu-PSMA-R2 for Metastatic prostate cancer|Adenocarcinoma of prostate. None/Not specified-controlled. 6 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic prostate cancer|Adenocarcinoma of prostate
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
13-05-2024
First CTIS Authorization Date
02-09-2024

Trial design

None/Not specified-controlled Phase I trial in France.

Comparator
None/Not specified
Target Sample Size
6

Recruitment

Planned Sample Size
6
Recruitment Window Months
15

Geography

Total Number Of Sites
1
Total Number Of Participants
6

France

Earliest CTIS Part Ii Submission Date
11-06-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
90
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Nuclear Medicine
Contact Person Name
Caroline ROUSSEAU
Number Of Participants
6

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
[64Cu]Cu-PSMA-R2
Active Substance
[64Cu]Cu-PSMA-R2
Modality
Radiopharmaceutical
Authorisation Status
Not authorised

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