RecruitingPhase 1NCT07006727

Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors

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


Sponsor

Novartis Pharmaceuticals

Enrollment

116 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I study testing a new radioactive cancer drug called [225Ac]Ac-ETN029, which targets a protein called DLL3 found on certain cancer cells. It is being tested in patients with advanced small-cell lung cancer or other rare neuroendocrine tumors. **You may be eligible if...** - You are 18 years or older - You have advanced small-cell lung cancer (SCLC) that progressed after at least one prior treatment including platinum-based chemotherapy - Or you have a large-cell neuroendocrine cancer of the lung, neuroendocrine prostate cancer, or a gastrointestinal/pancreatic high-grade neuroendocrine carcinoma that has progressed on prior treatment - Your cancer expresses the DLL3 protein (for expansion groups) - You have measurable disease on imaging **You may NOT be eligible if...** - Your cancer has not been previously treated - You do not have the DLL3 protein marker on your tumor (for expansion groups) - You are pregnant or breastfeeding - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG225Ac-ETN029

Radioligand therapy

DRUG111In-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

View Full Details on ClinicalTrials.gov

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NCT07006727


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