Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
225Ac-ETN029 · 1 trial · 11 indications
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 treatment-emergent adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs
Number of dose modifications (e.g, dose interruptions and reductions) for 225Ac-ETN029
Dose intensity of 225Ac-ETN029 defined as the ratio of actual cumulative dose received and actual duration of exposure
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029 |
| Name | Type | Description |
|---|---|---|
| 225Ac-ETN029 | DRUG | Radioligand therapy |
| 111In-ETN029 | DRUG | Radioligand imaging agent |
Inclusion 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 chemother...
225Ac-ETN029 is an investigational oncology therapy being developed by Novartis AG for Small Cell Lung Carcinoma and other advanced DLL3-expressing solid tumors. It is a small molecule in Phase 1 clinical development and has not been approved by the FDA. It is administered as a targeted treatment for patients with these tumor types.
225Ac-ETN029 is being studied for the treatment of Small Cell Lung Carcinoma and other advanced DLL3-expressing solid tumors. Its clinical program includes patients with large cell neuroendocrine carcinoma of the lung, neuroendocrine prostate cancer, gastroenteropancreatic neuroendocrine carcinoma, Merkel cell carcinoma, and medullary thyroid carcinoma, among other neuroendocrine tumor types.
Novartis AG, which trades under the ticker NVS, is the developer of 225Ac-ETN029. The company is running the clinical program for this investigational small molecule in advanced DLL3-expressing solid tumors, including Small Cell Lung Carcinoma.
225Ac-ETN029 is in Phase 1 clinical development. It is an investigational therapy and is not FDA approved. The Phase 1 program is currently recruiting participants and is designed to evaluate the drug in patients with advanced DLL3-expressing solid tumors, including Small Cell Lung Carcinoma.
225Ac-ETN029 is being evaluated in the Phase 1 study NCT07006727, titled a Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors. The trial is recruiting and plans to enroll 116 participants across the United States, Canada, Japan, and South Korea. It is an uncontrolled study in adults 18 years and older.