Tests a radioactive drug and imaging agent in adults with solid tumors
Tests a radioactive drug and imaging agent in adults with several solid cancers.
Plain-language title generated from the registry record
Registry title: Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
Key facts
- Where
- Essen, GermanySee the site
- Phase
- Phase 1
Where in Germany
- EssenEssen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07261631
- Record updated
- 9 October 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumorsRead full original descriptionShow less
A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
Inclusion: 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: 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; 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.