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 — DRUG
    Radioligand therapy
  • 111In-ETN029 — DRUG
    Radioligand 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 1
    Patients 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

Locations (4)

FacilityCityStateZIPSite coordinators
University Of IowaIowa CityIowa52242
Kellie Bodeker
319-356-2197
Yusuf Menda (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Mingyuan Tommy Song
Shadi Abdar Esfahani (PRINCIPAL_INVESTIGATOR)
Corewell Health William Beaum HospRoyal OakMichigan48073-6769
Matthew Johnson
248-898-2697
Andrew Thompson (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research CenterSeattleWashington98109-1024
Akshata Mathur
Delphine Chen (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

Related Studies