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

Recruiting now · Phase 1

Conditions studied: Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung, Neuroendocrine Prostate Cancer, Gastroenteropancreatic Neuroendocrine Carcinoma

In brief

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.

Key facts

Study ID

NCT07006727

Run by

Novartis Pharmaceuticals

People needed

116

Starts

2025-10-16

Expected to finish

2031-08-29

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Patients with one of the following indications:
• Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Prior DLL3-targeted therapy is allowed. For dose expansion, patients should have received no more than 2 prior lines of systemic therapy.
• Dose escalation only: LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy.
• Dose expansion only: Locally advanced, unresectable, or metastatic de novo or castration-resistant, treatment-emergent NEPC with neuroendocrine differentiation confirmed by local histology and NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC. Prior PSMA-targeted, Lu-177-based RLT is allowed. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT/CT as assessed by the Investigator.
• Dose expansion only: Locally advanced, unresectable, or metastatic GEP-NEC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT/CT as assessed by the Investigator.

You may not qualify if…

• Absolute neutrophil count (ANC) < 1.0 x 109/L, hemoglobin < 9 g/dL, or platelet count < 75 x 109/L
• QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
• eGFR < 60 mL/min (<0.835 mL/s), calculated using the CKD-EPI 2021 formula or measured
• Unmanageable urinary tract obstruction or urinary incontinence
• Presence of leptomeningeal disease, of symptomatic CNS metastases or of CNS metastases that require local CNS-directed therapy
• History of or current interstitial lung disease or pneumonitis ≥ Grade 2
• Any prior DLL3-targeted therapy (except for SCLC) and any prior RLT (except for NEPC)
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• University Of Iowa — Iowa City, Iowa, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Corewell Health William Beaum Hosp — Royal Oak, Michigan, United States (enrolling)
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
• Novartis Investigative Site — Montreal, Quebec, Canada (enrolling)
• Novartis Investigative Site — Seoul, Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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