Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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 this trial is running

• Novartis Investigative Site, Montreal, Quebec, Canada
• Novartis Investigative Site, Odense C, Denmark
• Novartis Investigative Site, Vandœuvre-lès-Nancy, France
• Novartis Investigative Site, Essen, Germany
• Novartis Investigative Site, Haifa, Israel
• Novartis Investigative Site, Tel Aviv, Israel
• Novartis Investigative Site, Singapore, Singapore
• Novartis Investigative Site, Singapore, Singapore

Who to contact

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07261631.