Trials / Recruiting

RecruitingNCT07006727

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 116 (estimated)

Sponsor: Novartis Pharmaceuticals · Industry
Sex: All
Age: 18 Years – 100 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	225Ac-ETN029	Radioligand therapy
DRUG	111In-ETN029	Radioligand imaging agent

Timeline

Start date: 2025-10-16
Primary completion: 2031-08-29
Completion: 2031-08-29
First posted: 2025-06-05
Last updated: 2026-03-24

Locations

5 sites across 3 countries: United States, Canada, South Korea

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07006727. Inclusion in this directory is not an endorsement.