Clinical trial • Phase I • Oncology
Anti-Ly6E exatecan for Advanced solid tumors | Non-small cell lung cancer | Triple-negative breast cancer | Pancreatic ductal adenocarcinoma | Gastric cancer | Ovarian epithelial cancer | Squamous cell carcinoma of head and neck
Phase I trial of Anti-Ly6E exatecan for Advanced solid tumors | Non-small cell lung cancer | Triple-negative breast cancer | Pancreatic ductal adenocarcin…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors | Non-small cell lung cancer | Triple-negative breast cancer | Pancreatic ductal adenocarcinoma | Gastric cancer | Ovarian epithelial cancer | Squamous cell carcinoma of head and neck
- Trial Stage
- Phase I
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 17-11-2025
- First CTIS Authorization Date
- 03-03-2026
Trial design
Phase I trial across 2 sites in Spain.
- Target Sample Size
- 44
Recruitment
- Planned Sample Size
- 44
- Recruitment Window Months
- 29
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 14
Spain
- Earliest CTIS Part Ii Submission Date
- 28-01-2026
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 34
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda Cabana
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
Sponsor
Primary sponsor
- Full Name
- Merck Healthcare KGaA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Anti-Ly6E Exatecan ADC M7437
- Active Substance
- Anti-Ly6E exatecan
- Modality
- ADC
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