Clinical trial • Phase I • Oncology
177Lu-EVG321 for Small cell lung cancer
Phase I trial of 177Lu-EVG321 for Small cell lung cancer. adaptive. 20 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small cell lung cancer
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 07-10-2024
- First CTIS Authorization Date
- 05-02-2025
Trial design
adaptive Phase I trial across 2 sites in Italy, Austria.
- Adaptive
- True - Dose-escalation scheme with protocol amendment informed by dosimetry data from the first treated subject; modifications to dose-escalation and patient selection including use of a companion diagnostic are described in the temporary halt justification.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 20
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 42
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 20
Italy
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 09-04-2025
- Processing Time Days
- 85
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Medicine and Surgery
- Principal Investigator Name
- Paola Anna Erba
- Principal Investigator Email
- perba@asst-pg23.it
- Contact Person Name
- Paola Anna Erba
- Contact Person Email
- perba@asst-pg23.it
- Number Of Participants
- 10
Austria
- Earliest CTIS Part Ii Submission Date
- 06-01-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 323
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- University Hospital for Nuclear Medicine
- Principal Investigator Name
- Irene Virgolini
- Principal Investigator Email
- irene.virgolini@i-med.ac.at
- Contact Person Name
- Irene Virgolini
- Contact Person Email
- irene.virgolini@i-med.ac.at
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Evergreen Theragnostics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- 177Lu-EVG321
- Modality
- Radiopharmaceutical
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