Targeted radioligand [177Lu]Lu-DFC413 for advanced pancreatic, lung, breast, and colorectal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase I trial uses a dose-escalation part followed by a dose-expansion part to identify recommended radioactive dose(s) and gather early activity signals. Eligible patients are imaged with [68Ga]Ga-NNS309 PET/CT or PET/MRI to confirm tumor targeting and to support dosimetry before treatment. In escalation, small cohorts receive increasing radioactive doses of [177Lu]Lu-DFC413 to determine safety, tolerability, and organ radiation exposure; the expansion enrolls disease-specific cohorts at the selected dose(s). Patients are followed for adverse events, preliminary anti-tumor activity, and long-term outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• United Theranostics
  Princeton, New Jersey, United States Recruiting
• Novartis Investigative Site
  Montreal, Quebec, Canada Recruiting
• Novartis Investigative Site
  Odense C, Denmark Recruiting
• Novartis Investigative Site
  Vandœuvre-lès-Nancy, France Recruiting
• Novartis Investigative Site
  Essen, Germany Recruiting
• Novartis Investigative Site
  Haifa, Israel Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.