Clinical trial • Phase I • Oncology
ES2B-C001 for HER2-positive breast cancer|Metastatic breast cancer|Locally advanced unresectable breast cancer
Phase I trial of ES2B-C001 for HER2-positive breast cancer|Metastatic breast cancer|Locally advanced unresectable breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- HER2-positive breast cancer|Metastatic breast cancer|Locally advanced unresectable breast cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 06-08-2024
- First CTIS Authorization Date
- 02-12-2024
Trial design
None/Not specified-controlled Phase I trial across 3 sites in Austria.
- Comparator
- None/Not specified
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable populations selected (isVulnerablePopulationSelected true); no details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable populations selected (isVulnerablePopulationSelected true); no details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 20
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 40
Austria
- Earliest CTIS Part Ii Submission Date
- 11-11-2024
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 501
- Number Of Sites
- 3
- Number Of Participants
- 40
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Clinical Pharmacology
- Principal Investigator Name
- Bernd Jilma
- Principal Investigator Email
- bernd.jilma@meduniwien.ac.at
- Contact Person Name
- Bernd Jilma
- Contact Person Email
- bernd.jilma@meduniwien.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Internal Medicine I
- Principal Investigator Name
- Renate Pusch
- Principal Investigator Email
- renate.pusch@ordensklinikum.at
- Contact Person Name
- Renate Pusch
- Contact Person Email
- renate.pusch@ordensklinikum.at
- Site Name
- Medical University Of Graz
- Department Name
- Division of Oncology
- Principal Investigator Name
- Gabriel Rinnerthaler
- Principal Investigator Email
- gabriel.rinnerthaler@medunigraz.at
- Contact Person Name
- Gabriel Rinnerthaler
- Contact Person Email
- gabriel.rinnerthaler@medunigraz.at
Sponsor
Primary sponsor
- Full Name
- Expres2ion Biotechnologies ApS
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Investigational products
- Investigational Product Name
- ES2B-C001
- First In Human
- Yes
- Combination Treatment
- Yes
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