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Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[225Ac\]Ac-ETN029 and the safety and imaging properties of \[111In\]In-ETN029 in patients aged ≥ 18 years with locally advanced or metastatic DLL3 positive cancers.
Official title: A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2025-10-16
Completion Date
2031-08-29
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
225Ac-ETN029
Radioligand therapy
111In-ETN029
Radioligand imaging agent
Locations (5)
University Of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Corewell Health William Beaum Hosp
Royal Oak, Michigan, United States
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Seoul, Korea, South Korea