Recruiting
Phase 1

225Ac-ETN029, 111In-ETN029

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07006727

Conditions

Small Cell Lung Carcinoma

Large Cell Neuroendocrine Carcinoma of the Lung

Neuroendocrine Prostate Cancer

Gastroenteropancreatic Neuroendocrine Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

225Ac-ETN029

111In-ETN029

Study Details

Brief 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.

Conditions

Small Cell Lung Carcinoma

Large Cell Neuroendocrine Carcinoma of the Lung

Neuroendocrine Prostate Cancer

Gastroenteropancreatic Neuroendocrine Carcinoma

Study ID

NCT07006727

Start date

Oct 16, 2025

Status verified date

Jul, 2026

Completion date

Aug 29, 2031

Anticipated

Primary completion date

Aug 29, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

116 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029

Interventions

225Ac-ETN029

Radioligand therapy

111In-ETN029

Radioligand imaging agent

Primary outcome measure

  • Number of patients with dose limiting toxicities of 225Ac-ETN029 [ Time Frame: From the start of study treatment until 6 weeks after ]
  • Incidence and severity of adverse events and serious adverse events of 225Ac-ETN029 [ Time Frame: From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months ]
  • Dose modifications for 225Ac-ETN029 [ Time Frame: From the start of study treatment until last dose of study treatment, assessed as approximately 24 weeks ]
  • Dose intensity for 225Ac-ETN029 [ Time Frame: From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

University Of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kristin West

+1 319 356 2197kristin-west@uiowa.edu

Principal Investigator:

Yusuf Menda

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Mingyuan Tommy Song

msong15@mgh.harvard.edu

Principal Investigator:

Shadi Abdar Esfahani

Corewell Health William Beaum Hosp

Recruiting

Royal Oak, Michigan, United States, 48073-6769

Contacts

Matthew Johnson

+1 248 898 2697matthew.johnson3@corewellhealth.org

Principal Investigator:

Andrew Thompson

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-1024

Contacts

Caitie Moore

cmoore2@fredhutch.org

Principal Investigator:

Delphine Chen

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Small Cell Lung Carcinoma (SCLC)
  • Large Cell Neuroendocrine Carcinoma of the Lung (LCNEC)
  • Neuroendocrine Prostate Cancer (NEPC)
  • Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
  • DLL3
  • Neuroendocrine neoplasms
  • Radioligand therapy (RLT)
  • [225Ac]Ac-ETN029
  • [111In]In-ETN029

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-28.