Clinical trial • Phase I/II • Oncology
TT125-802 for Advanced non-small cell lung cancer
Phase I/II trial of TT125-802 for Advanced non-small cell lung cancer. open-label. 130 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced non-small cell lung cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-03-2025
- First CTIS Authorization Date
- 27-06-2025
Trial design
open-label Phase I/II trial across 3 sites in Spain.
- Open Label
- Yes
- Biomarker Stratified
- True; biomarkers: KRAS mutation, EGFR gene mutation
- Target Sample Size
- 130
Recruitment
- Planned Sample Size
- 130
- Recruitment Window Months
- 33
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 130
Spain
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 248
- Number Of Sites
- 3
- Number Of Participants
- 40
Sites
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Phase I Unit
- Contact Person Name
- Omar Saavedra
- Contact Person Email
- osaavedra@nextoncology.eu
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Therapeutic Innovation and Precision Medicine section
- Contact Person Name
- Santiago Ponce Aix
- Contact Person Email
- santiago.ponce@oncosur.org
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- NEXT Madrid Phase I trials
- Contact Person Name
- Jesús Fuentes Antras
- Contact Person Email
- jfuentesantras@nextoncology.eu
Sponsor
Primary sponsor
- Full Name
- TOLREMO therapeutics AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- TT125-802
- Active Substance
- TT125-802
- Modality
- Other
- Investigational Product Name
- adagrasib
- Active Substance
- adagrasib
- Modality
- Small molecule
- Investigational Product Name
- osimertinib
- Active Substance
- osimertinib
- Modality
- Small molecule
- Investigational Product Name
- docetaxel
- Active Substance
- docetaxel
- Modality
- Small molecule
- Combination Treatment
- Yes
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