Clinical trial • Phase I • Oncology

Trastuzumab for Breast cancer|Gastroesophageal adenocarcinoma|ERBB2 (HER2) gene-altered cancers

Phase I trial of Trastuzumab for Breast cancer|Gastroesophageal adenocarcinoma|ERBB2 (HER2) gene-altered cancers. 140 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer|Gastroesophageal adenocarcinoma|ERBB2 (HER2) gene-altered cancers
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical|Monoclonal antibody

Key dates

Initial CTIS Submission Date
06-08-2024
First CTIS Authorization Date
05-11-2024

Trial design

Phase I trial across 1 site in Denmark.

Target Sample Size
140
Trial Duration For Participant
1461

Recruitment

Planned Sample Size
140
Recruitment Window Months
48

Geography

Total Number Of Sites
1
Total Number Of Participants
140

Denmark

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
04-06-2025
Processing Time Days
239
Number Of Sites
1
Number Of Participants
140

Sites

Site Name
Rigshospitalet
Department Name
Department of Clinical Physiology and Nuclear Medicine
Contact Person Name
Malene Martini Clausen

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
Site-Specific Labelled 89Zr-Trastuzumab
Active Substance
Trastuzumab
Modality
Radiopharmaceutical|Monoclonal antibody

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