Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07006727
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Gastroenteropancreatic Neuroendocrine Carcinoma
- Large Cell Neuroendocrine Carcinoma of the Lung
- Neuroendocrine Prostate Cancer
- Small Cell Lung Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- 225Ac-ETN029 — DRUGRadioligand therapy
- 111In-ETN029 — DRUGRadioligand imaging agent
Study Details
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.
Key Dates
- Start date
- Oct 16, 2025
- Status verified
- May 2026
- Primary completion
- Aug 29, 2031
- Completion
- Aug 29, 2031
Study Design
- Enrollment
- 116 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029
Primary Outcome Measure
Number of patients with dose limiting toxicities of 225Ac-ETN029 [ Time Frame: From the start of study treatment until 6 weeks after ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Of Iowa | Iowa City | Iowa | 52242 | Yusuf Menda (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Mingyuan Tommy Song Shadi Abdar Esfahani (PRINCIPAL_INVESTIGATOR) |
| Corewell Health William Beaum Hosp | Royal Oak | Michigan | 48073-6769 | Andrew Thompson (PRINCIPAL_INVESTIGATOR) |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | Akshata Mathur Delphine Chen (PRINCIPAL_INVESTIGATOR) |
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