Clinical trial • Phase I • Oncology
Oncolytic adenovirus encoding tumor necrosis factor alpha (TNF-alpha) and interleukin-2 (IL-2) for Solid Tumors
Phase I trial of Oncolytic adenovirus encoding tumor necrosis factor alpha (TNF-alpha) and interleukin-2 (IL-2) for Solid Tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid Tumors
- Trial Stage
- Phase I
- Drug Modality
- Gene therapy
Key dates
- Initial CTIS Submission Date
- 16-12-2024
- First CTIS Authorization Date
- 20-12-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 2 sites in Finland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation design; no further details available in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 39
Recruitment
- Planned Sample Size
- 39
- Recruitment Window Months
- 54
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 39
Finland
- Earliest CTIS Part Ii Submission Date
- 16-12-2024
- Latest Decision Or Authorization Date
- 20-12-2024
- Processing Time Days
- 4
- Number Of Sites
- 2
- Number Of Participants
- 39
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Clinical
- Contact Person Name
- Katriina Jalkanen
- Contact Person Email
- katriina.jalkanen@hus.fi
- Site Name
- Docrates Oy
- Department Name
- Clinical
- Contact Person Name
- Tuomo Alanko
- Contact Person Email
- Tuomo.Alanko@docrates.com
Sponsor
Primary sponsor
- Full Name
- TILT Biotherapeutics Oy
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123)
- Active Substance
- Oncolytic adenovirus encoding tumor necrosis factor alpha (TNF-alpha) and interleukin-2 (IL-2)
- Modality
- Gene therapy
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