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 small molecule radiopharmaceutical being developed by Novartis AG for the treatment of advanced DLL3-expressing solid tumors, including small cell lung carcinoma. It is in Phase 1 clinical development and is not yet approved for any indication.
225Ac-ETN029 is being studied for the treatment of advanced DLL3-expressing solid tumors, with small cell lung carcinoma as a lead indication. The Phase 1 trial also enrolls patients with other neuroendocrine carcinomas, including large cell neuroendocrine carcinoma of the lung and neuroendocrine prostate cancer.
225Ac-ETN029 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the ongoing Phase 1 clinical program evaluating the agent in advanced DLL3-expressing solid tumors.
225Ac-ETN029 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The single ongoing trial is currently recruiting participants.
225Ac-ETN029 is being evaluated in one clinical trial, 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.
Yes. The Phase 1 trial NCT07006727 enrolls patients whose tumors express DLL3, making 225Ac-ETN029 a biomarker-selected therapy. Eligible participants must be at least 18 years of age, and the study is open to all sexes. It is an uncontrolled, non-randomized, open-label study.