Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Launched by NOVARTIS PHARMACEUTICALS · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called [177Lu]Lu-NNS309 for patients with advanced stages of certain types of cancer, including pancreatic, lung, breast, and colorectal cancers. The main goals are to see how safe this treatment is, how well it is tolerated by patients, and to gather early information on how effective it may be. The trial is currently looking for participants who are 18 years or older and have already tried other treatments without success. Specifically, patients with pancreatic cancer, non-small cell lung cancer, certain types of breast cancer, and colorectal cancer that has spread or cannot be surgically removed may be eligible.

If you join the trial, you will receive the new treatment and be closely monitored for any side effects or changes in your condition. Participants will also undergo imaging tests to help doctors understand how the treatment is affecting the cancer. It’s important to know that there are specific health requirements to be eligible, such as having certain blood counts and being free from specific medical issues. This trial aims to provide hope for patients who have not responded to other treatments, and your participation could help advance cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• * Patients with one of the following indications:
• • Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, 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 targeted therapy, unless patient was ineligible to receive such therapy
• • Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
• • Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
• • (Dose escalation part only) 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
• • 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
• • Creatinine clearance \< 60 mL/min
• • Unmanageable urinary tract obstruction or urinary incontinence
• • Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-NNS309
• • Other protocol-defined inclusion/exclusion criteria may apply.