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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