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OncoMatch/Clinical Trials/NCT07006727

Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors

Is NCT07006727 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including 225Ac-ETN029 and 111In-ETN029 for small cell lung carcinoma.

Phase 1RecruitingNovartis PharmaceuticalsNCT07006727Data as of Jun 2026Location: United States · Canada · South Korea

Treatment: 225Ac-ETN029 · 111In-ETN029The 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.

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Extracted eligibility criteria

Treatments studied

Radioligand therapy

225Ac-ETN029

Other

111In-ETN029

Cancer type

Small Cell Lung Cancer

Neuroendocrine Tumor

Non-Small Cell Lung Carcinoma

Pancreatic Cancer

Biomarker criteria

Required: DLL3 expression

Advanced DLL3-expressing solid tumors

Required: CHGA expression

NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC

Required: SYP expression

NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC

Demographics

Ages ≤ 100

Prior therapy

Min 1 prior line

Must have received: systemic therapy

disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy

Cannot have received: DLL3-targeted therapy

Exception: SCLC indication

Any prior DLL3-targeted therapy (except for SCLC)

Cannot have received: radioligand therapy

Exception: NEPC indication

any prior RLT (except for NEPC)

Lab requirements

Blood counts

ANC < 1.0 x 10^9/L, hemoglobin < 9 g/dL, or platelet count < 75 x 10^9/L [excluded]

Kidney function

eGFR < 60 mL/min (<0.835 mL/s), calculated using the CKD-EPI 2021 formula or measured [excluded]

Cardiac function

QTcF ≥ 470 msec [excluded]

ANC < 1.0 x 10^9/L, hemoglobin < 9 g/dL, or platelet count < 75 x 10^9/L; QTcF ≥ 470 msec; eGFR < 60 mL/min (<0.835 mL/s), calculated using the CKD-EPI 2021 formula or measured

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University Of Iowa · Iowa City, Iowa
  • Massachusetts General Hospital · Boston, Massachusetts
  • Corewell Health William Beaum Hosp · Royal Oak, Michigan
  • Fred Hutchinson Cancer Research Center · Seattle, Washington

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07006727 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior DLL3-targeted therapy, radioligand therapy disqualifies patients from enrollment.

Does this trial require DLL3?

Yes, DLL3 expression is a required biomarker for enrollment.

Does this trial require CHGA?

Yes, CHGA expression is a required biomarker for enrollment.

Does this trial require SYP?

Yes, SYP expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 100 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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