Back to search results

Phase I Study of [225Ac]Ac-ETN029 for Advanced DLL3-expressing Solid Tumors

This study is testing a new treatment called [225Ac]Ac-ETN029 (a radioligand therapy) for people with advanced solid tumors that have a specific marker called DLL3. This includes certain types of lung cancer (Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma), prostate cancer (Neuroendocrine Prostate Cancer), and cancers of the digestive system (Gastroenteropancreatic Neuroendocrine Carcinoma). The main goals are to see how safe [225Ac]Ac-ETN029 is, how well your body tolerates it, and to get an early look at how effective it might be. Another drug, [111In]In-ETN029, will also be used for imaging. You may be able to join if you are 18 or older and have one of these cancers that has progressed after other treatments. The study is currently unclear on its recruitment status and plans to enroll 116 participants.

Study design
This is a Phase I, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 116 participants and has two parts: a dose escalation part to find the right dose, and a dose expansion part to further study safety and effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety for up to 36 months after starting treatment, with assessments up to approximately 42 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07006727

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~116 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:225Ac-ETN029111In-ETN029

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose limiting toxicities of 225Ac-ETN029
Measured over From the start of study treatment until 6 weeks after
+3 more outcomes measured

Conditions

Small Cell Lung Carcinoma
Large Cell Neuroendocrine Carcinoma of the Lung
Neuroendocrine Prostate Cancer
Gastroenteropancreatic Neuroendocrine Carcinoma

Explore related trials

Gastroenteropancreatic Neuroendocrine CarcinomaLung Large Cell Neuroendocrine CarcinomaLung Small Cell CarcinomaProstate Carcinoma111In-ETN029

Where it's being run

7 sites across 7 states
Iowa1
Massachusetts1
Michigan1
Washington1
Quebec1
Seoul1
South Korea1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Number of patients with dose limiting toxicities of 225Ac-ETN029From the start of study treatment until 6 weeks after

    A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE 5.0 grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.

  • Incidence and severity of adverse events and serious adverse events of 225Ac-ETN029From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months

    Incidence and severity of treatment-emergent adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs

  • Dose modifications for 225Ac-ETN029From the start of study treatment until last dose of study treatment, assessed as approximately 24 weeks

    Number of dose modifications (e.g, dose interruptions and reductions) for 225Ac-ETN029

  • Dose intensity for 225Ac-ETN029From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks

    Dose intensity of 225Ac-ETN029 defined as the ratio of actual cumulative dose received and actual duration of exposure