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225Ac-ETN029

Phase 1

Small Cell Lung Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: Jul 28, 2026

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

225Ac-ETN029 · 1 trial · 4 indications

Phase 1 1
NCT07006727Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid TumorsSmall Cell Lung Carcinoma
RECRUITING116 Analytics
PHASE1RECRUITING
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
Small Cell Lung CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with dose limiting toxicities of 225Ac-ETN029
From the start of study treatment until 6 weeks after

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 adverse events and serious adverse events of 225Ac-ETN029
From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months

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

Dose modifications for 225Ac-ETN029
From the start of study treatment until last dose of study treatment, assessed as approximately 24 weeks

Number of dose modifications (e.g, dose interruptions and reductions) for 225Ac-ETN029

Dose intensity for 225Ac-ETN029
From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks

Dose intensity of 225Ac-ETN029 defined as the ratio of actual cumulative dose received and actual duration of exposure

Secondary Endpoints

Overall response rate (ORR)
Up to approximately 42 months
Disease control rate (DCR)
Up to approximately 42 months
Duration of response (DOR)
Up to approximately 42 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALPatients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029

Interventions

NameTypeDescription
225Ac-ETN029DRUGRadioligand therapy
111In-ETN029DRUGRadioligand imaging agent
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Age ≥ 18 years old * Patients with one of the following indications: * Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ...

Countries:United StatesCanadaSouth Korea
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Recent Changes (Last 90 Days)

LOWJul 28, 2026NCT07006727lastUpdatePostDate: changed
LOWJul 28, 2026NCT07006727lastUpdatePostDate: changed

Frequently asked questions about 225Ac-ETN029

What is 225Ac-ETN029 used for in Small Cell Lung Carcinoma?

225Ac-ETN029 is an investigational small molecule being studied for the treatment of Small Cell Lung Carcinoma. It is currently in Phase 1 clinical development, with an active trial recruiting patients with advanced DLL3-expressing solid tumors, including Small Cell Lung Carcinoma.

What does 225Ac-ETN029 target?

225Ac-ETN029 targets DLL3, a protein expressed on the surface of certain tumor cells. The drug is designed to deliver a radioactive payload to DLL3-expressing tumors, potentially enabling targeted treatment of cancers such as Small Cell Lung Carcinoma.

Who makes 225Ac-ETN029?

225Ac-ETN029 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced DLL3-expressing solid tumors.

What phase is 225Ac-ETN029 in?

225Ac-ETN029 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants to assess the safety and tolerability of the drug.

What clinical trials is 225Ac-ETN029 in?

225Ac-ETN029 is being evaluated in a Phase 1 clinical trial with the identifier NCT07006727. This open-label, uncontrolled study is recruiting 116 participants with advanced DLL3-expressing solid tumors, including Small Cell Lung Carcinoma, at sites in the United States, Canada, and South Korea.