Clinical trial • Phase I • Oncology

Clinical trial in HER2-positive tumors

Phase I trial for HER2-positive tumors. None/Not specified-controlled. 28 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-positive tumors
Trial Stage
Phase I
Drug Modality
Diagnostic agent

Key dates

Initial CTIS Submission Date
06-05-2025
First CTIS Authorization Date
07-08-2025

Trial design

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

Comparator
None/Not specified
Target Sample Size
28

Recruitment

Planned Sample Size
28
Recruitment Window Months
16

Geography

Total Number Of Sites
1
Total Number Of Participants
28

Netherlands

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
244
Number Of Sites
1
Number Of Participants
28

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Imaging, Nuclear Medicine
Principal Investigator Name
James Nagarajah
Principal Investigator Email
james.nagarajah@radboudumc.nl
Contact Person Name
James Nagarajah
Contact Person Email
james.nagarajah@radboudumc.nl
Number Of Participants
28

Sponsor

Primary sponsor

Full Name
Radboud universitair medisch centrum Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

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