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225Ac-ETN029

Phase 1

Small Cell Lung Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: May 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07006727Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid TumorsPHASE1 RECRUITING 116Oct 16, 2025Aug 29, 2031May 5, 20266 United States, Canada +1
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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 — 100 Years
SexALL
Healthy VolunteersNo
Study Sites6

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)
LOWMay 26, 2026NCT07006727primaryCompletionDate: changed
LOWMay 24, 2026NCT07006727studyFirstPostDate: changed