Small Cell Lung Carcinoma study: 225Ac-ETN029 vs 111In-ETN029
Official title Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
ClinicalTrials.gov ID: NCT07006727
What this study is testing
What is 225Ac-ETN029?
This is an investigational radioligand therapy being studied as a potential treatment for small cell lung cancer. It is designed to attach to specific targets on cancer cells and deliver radiation directly to them.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe the drug is, how well it is tolerated, how it distributes in the body, and whether it shows any early signs of working. It also will check the imaging properties of a related compound.
- Who it's for
- Adults 18 years or older with locally advanced or metastatic cancers that express DLL3, such as small cell lung cancer, neuroendocrine prostate cancer, and other listed neuroendocrine tumors.
- What's involved
- Participants will receive injections of two radiolabeled compounds, [225Ac]Ac‑ETN029 and [111In]In‑ETN029, and will have blood tests, imaging scans, and safety monitoring during the study.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Age ≥ 18 years old
- Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy...
- LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing...
- Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) confirmed by local histopathology, for whom no standard therapy is...
- Locally advanced, unresectable, or metastatic GEP-NEC, cervical NEC, genitourinary NEC, thymic NEC, Merkel cell carcinoma, or unknown primary NEC...
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years old
- 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...
- 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.
- 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...
- 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...
- 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.
- 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...
- 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/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Royal Oak, Michigan, United States
- Seattle, Washington, United States
- Montreal, Quebec, Canada
- Chuo Ku, Tokyo, Japan
- Seoul, Seoul, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Iowa City, Iowa, United States; Boston, Massachusetts, United States; Royal Oak, Michigan, United States; Seattle, Washington, United States; Montreal, Quebec, Canada; Chuo Ku, Tokyo, Japan and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.