Clinical trial • Phase I • Oncology
TH9619 for Solid tumors | Non-small cell lung cancer | Colorectal cancer | Head and neck cancer | Gastric cancer
Phase I trial of TH9619 for Solid tumors | Non-small cell lung cancer | Colorectal cancer | Head and neck cancer | Gastric cancer. 43 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumors | Non-small cell lung cancer | Colorectal cancer | Head and neck cancer | Gastric cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 16-12-2024
- First CTIS Authorization Date
- 11-04-2025
Trial design
Phase I trial across 3 sites in France, Spain.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 43
Eligibility
Recruits 43 No vulnerable population selected; no consent/assent details provided in the record..
- Vulnerable Population
- No vulnerable population selected; no consent/assent details provided in the record.
Recruitment
- Planned Sample Size
- 43
- Recruitment Window Months
- 20
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 33
France
- Earliest CTIS Part Ii Submission Date
- 24-01-2025
- Latest Decision Or Authorization Date
- 09-12-2025
- Processing Time Days
- 319
- Number Of Sites
- 1
- Number Of Participants
- 17
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- GI Oncology
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 29-07-2025
- Processing Time Days
- 137
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Victor Moreno
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- Medical Oncology
- Principal Investigator Name
- Gaspar Joaquin Molina Lores
- Principal Investigator Email
- gasparmolina@vhio.net
- Contact Person Name
- Gaspar Joaquin Molina Lores
- Contact Person Email
- gasparmolina@vhio.net
Sponsor
Primary sponsor
- Full Name
- One-carbon Therapeutics AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- TH9619
- First In Human
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)