Actively Recruiting
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Led by Novartis Pharmaceuticals · Updated on 2026-05-05
116
Participants Needed
6
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of locally advanced, unresectable, or metastatic small cell lung carcinoma with disease progression after or intolerance to at least 1 line of systemic therapy including platinum chemotherapy, unless ineligible for such therapy
- Prior DLL3-targeted therapy allowed
- For dose expansion, no more than 2 prior systemic therapy lines
- Dose escalation only: Large cell neuroendocrine carcinoma of the lung with disease progression after or intolerance to at least 1 line of systemic therapy including platinum chemotherapy, unless ineligible
- Dose expansion only: Locally advanced, unresectable, or metastatic neuroendocrine prostate cancer with neuroendocrine differentiation confirmed by local histology and markers, with at least one measurable lesion showing uptake of [111In]In-ETN029 on SPECT/CT
- Dose expansion only: Locally advanced, unresectable, or metastatic gastroenteropancreatic neuroendocrine carcinoma with disease progression after or intolerance to at least 1 line of systemic therapy including platinum chemotherapy, with at least one measurable lesion showing uptake of [111In]In-ETN029 on SPECT/CT
You will not qualify if you...
- Absolute neutrophil count less than 1.0 x 10^9/L, hemoglobin less than 9 g/dL, or platelet count less than 75 x 10^9/L
- Corrected QT interval (QTcF) of 470 milliseconds or greater
- Estimated glomerular filtration rate less than 60 mL/min (0.835 mL/s)
- Unmanageable urinary tract obstruction or urinary incontinence
- Presence of leptomeningeal disease, symptomatic central nervous system metastases, or CNS metastases requiring local therapy
- History or current interstitial lung disease or pneumonitis grade 2 or higher
- Any prior DLL3-targeted therapy except for small cell lung carcinoma
- Any prior radioligand therapy except for neuroendocrine prostate cancer
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University Of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Corewell Health William Beaum Hosp
Royal Oak, Michigan, United States, 48073-6769
Actively Recruiting
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Actively Recruiting
5
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
6
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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