Radioactive drug takes aim at Hard-to-Treat cancers
NCT ID NCT07261631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new radioactive drug (177Lu-DFC413) to see if it is safe and can shrink tumors in people with advanced solid cancers like pancreatic, lung, breast, colorectal, and sarcoma. About 180 adults whose cancer has progressed after standard treatments will receive the drug. The study also tests a companion imaging agent (68Ga-NNS309) to help see where the drug goes in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a radioactive drug (177Lu-DFC413) and a diagnostic imaging agent (68Ga-NNS309)
- What this could lead to
- If successful, this could point toward a new targeted radiation treatment for several hard-to-treat cancers.
- What could go wrong
- This is an early Phase 1 trial with only 180 participants, so the main goal is safety, not proof of effectiveness. The treatment may cause side effects or not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults ≥ 18 years with one of the following indications: * Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy * Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy * (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy * Patients must have lesions showing 68Ga-NNS309 uptake Exclusion Criteria: * Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 109/L * QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec * eGFR \< 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured * Unmanageable urinary tract obstruction or urinary incontinence * Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy * Any prior radioligand therapy * Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-DFC413 Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Novartis Investigative Site
RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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Novartis Investigative Site
RECRUITINGOdense C, 5000, Denmark
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Novartis Investigative Site
RECRUITINGVandœuvre-lès-Nancy, 54511, France
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Novartis Investigative Site
RECRUITINGEssen, 45147, Germany
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Novartis Investigative Site
RECRUITINGHaifa, 3109601, Israel
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Novartis Investigative Site
RECRUITINGTel Aviv, 6423906, Israel
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Novartis Investigative Site
RECRUITINGSingapore, 119228, Singapore
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Novartis Investigative Site
RECRUITINGSingapore, 168583, Singapore
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