Clinical trial • Phase I • Oncology
TK-6302 for Advanced PRAME-positive solid tumors
Phase I trial of TK-6302 for Advanced PRAME-positive solid tumors. 24 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced PRAME-positive solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 12-11-2025
- First CTIS Authorization Date
- 27-02-2026
Trial design
Phase I trial across 3 sites in Germany.
- Biomarker Stratified
- True, biomarkers: HLA-A02:01; PRAME expression
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 24
- Trial Duration For Participant
- 1826
Eligibility
Recruits 24 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 60
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 24
Germany
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 45
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Med. Klinik m. S. Haematologie, Onkologie und Tumorimmunologie
- Principal Investigator Name
- Antonia Busse
- Principal Investigator Email
- antonia.busse@charite.de
- Contact Person Name
- Antonia Busse
- Contact Person Email
- antonia.busse@charite.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Zentrum fuer Onkologie, II. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Winfried Alsdorf
- Principal Investigator Email
- w.alsdorf@uke.de
- Contact Person Name
- Winfried Alsdorf
- Contact Person Email
- w.alsdorf@uke.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Early Clinical Trial Unit (NCT/UCC ECTU)
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- Martin.Wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- Martin.Wermke@uniklinikum-dresden.de
Sponsor
Primary sponsor
- Full Name
- T-Knife GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- TK-6302
- First In Human
- Yes
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