Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Start Date
10/16/2025
Completion Date
8/29/2031
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.
Detailed Description
This is a phase I, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of 225Ac-ETN029 in patients with advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) of 225Ac-ETN029 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of 225Ac-ETN029. The study will also enable an initial evaluation of the safety, dosimetry, PK, and imaging properties of 111In-ETN029.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
225Ac-ETN029
111In-ETN029
Conditions
Locations
University Of Iowa
Iowa City, Iowa 52242
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Corewell Health William Beaum Hosp
Royal Oak, Michigan 48073-6769
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-1024
United States
Novartis Investigative Site
Montreal, Quebec H3T 1E2
Canada
Novartis Investigative Site
Seoul, Seoul 03080
South Korea
Novartis Investigative Site
Seoul, 03722
South Korea