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

Summary

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety, dosimetry and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Interventions

• [68Ga]Ga-NNS309 · DRUG

  Radioligand imaging agent

• [177Lu]Lu-NNS309 · DRUG

  Radioligand therapy

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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
* 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 10\^9/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 10\^9/L
* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
* Calculated estimated glomerular filtration rate \< 60 mL/min/1.73m2
* 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.

Sites (29)

• Uni of Alabama at Birmingham, Birmingham, Alabama · RECRUITING
• University of California LA, Los Angeles, California · RECRUITING
• Stanford University Medical Center, Palo Alto, California · RECRUITING
• Mayo Clinic Jacksonville, Jacksonville, Florida · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• BAMF Health, Grand Rapids, Michigan · RECRUITING
• Mayo Clinic Rochester, Rochester, Minnesota · RECRUITING
• Uni Of TX MD Anderson Cancer Cntr, Houston, Texas · RECRUITING
• University Of Washington, Seattle, Washington · RECRUITING
• Novartis Investigative Site, Brussels, Belgium · RECRUITING
• Novartis Investigative Site, Toronto, Ontario, Canada · RECRUITING
• Novartis Investigative Site, Montreal, Quebec, Canada · RECRUITING
• Novartis Investigative Site, Montreal, Quebec, Canada · RECRUITING
• Novartis Investigative Site, Bron, France · RECRUITING
• Novartis Investigative Site, Villejuif, France · RECRUITING
• Novartis Investigative Site, Cologne, North Rhine-Westphalia, Germany · RECRUITING
• Novartis Investigative Site, Essen, Germany · RECRUITING
• Novartis Investigative Site, München, Germany · RECRUITING
• Novartis Investigative Site, Rostock, Germany · RECRUITING
• Novartis Investigative Site, Tel Aviv, Israel · RECRUITING
• Novartis Investigative Site, Milan, MI, Italy · RECRUITING
• Novartis Investigative Site, Reggio Emilia, RE, Italy · RECRUITING
• Novartis Investigative Site, Nijmegen, Gelderland, Netherlands · RECRUITING
• Novartis Investigative Site, Utrecht, Netherlands · RECRUITING
• Novartis Investigative Site, Barcelona, Spain · RECRUITING
• Novartis Investigative Site, Madrid, Spain · RECRUITING
• Novartis Investigative Site, Madrid, Spain · RECRUITING
• Novartis Investigative Site, Geneva, Switzerland · RECRUITING
• Novartis Investigative Site, Lausanne, Switzerland · RECRUITING