RecruitingPhase 1NCT07006727
Official study titlePhase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Study 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.
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Key things to know
Main goalTreatment
This describes the study’s primary purpose.
What is being studied225Ac-ETN029 and 111In-ETN029
The study team can explain what participation involves.
Who it may be forSmall cell lung cancer (SCLC) · Locally advanced · Metastatic or stage IV
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 22, 2026 · Source: ClinicalTrials.gov
Is enrollment open?Recruiting
The study is currently accepting participants.
What kind of study?Phase 1
Interventional
Where is it offered?8 U.S. locations
Locations may change over time.
Who runs it?Novartis Pharmaceuticals
Study sponsor
Study overview
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: 225Ac-ETN029; Drug: 111In-ETN029
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How this study is categorized
These labels come from structured fields and exact terms in the public record.
Cancer type
Disease setting
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion criteria
- Age ≥ 18 years old
- Patients with one of the following indications: Dose Escalation Only:
- Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy (prior DLL3-targeted therapy allowed).
- LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy.
- Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) confirmed by local histopathology, for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment. Prior RLT is not allowed, though exceptions can be made following discussion with Novartis Medical Monitor.
- Locally advanced, unresectable, or metastatic GEP-NEC, cervical NEC, genitourinary NEC, thymic NEC, Merkel cell carcinoma, or unknown primary NEC with disease progression following, or intolerance to, at least one line of systemic therapy (including platinum-containing chemotherapy for non-MCC indications, or PD-1 or PD-L1 inhibition for MCC, unless patient was ineligible to receive such therapy), and for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment.
- Locally advanced, unresectable, or metastatic medullary thyroid cancer with disease progression following, or intolerance to, at least 1 line of systemic therapy (unless patient was ineligible to receive such therapy), and for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment. Dose expansion only:
- Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy (prior DLL3-targeted therapy allowed). Patients should have received no more than 2 prior lines of systemic therapy.
- 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. 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.
- 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.
Reasons someone may not be able to joinExclusion criteria
- Absolute neutrophil count (ANC) \< 1.0 x 10\^9/L, hemoglobin \< 9 g/dL, or platelet count \< 75 x 10\^9/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- eGFR \< 60 mL/min/1.73m2 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)
- Any prior RLT (except for NEPC patients in expansion) Other protocol-defined inclusion/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- University Of IowaIowa City, Iowa
- Massachusetts General HospitalBoston, Massachusetts
- Corewell Health William Beaum HospRoyal Oak, Michigan
- Fred Hutchinson Cancer Research CenterSeattle, Washington
- Novartis Investigative SiteMontreal, Quebec
- Novartis Investigative SiteChuo Ku, Tokyo
- Novartis Investigative SiteSeoul, Seoul
- Novartis Investigative SiteSeoul
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 22, 2026. Always confirm current availability with the study team.