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Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety 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).
Official title: Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2024-10-15
Completion Date
2031-01-16
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
[68Ga]Ga-NNS309
Radioligand imaging agent
[177Lu]Lu-NNS309
Radioligand therapy
Locations (31)
Uni of Alabama at Birmingham
Birmingham, Alabama, United States
University of California LA
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
BAMF Health
Grand Rapids, Michigan, United States
BAMF Health
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
University Of Washington
Seattle, Washington, United States
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Bron, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Reggio Emilia, RE, Italy
Novartis Investigative Site
Nijmegen, Gelderland, Netherlands
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Geneva, Switzerland
Novartis Investigative Site
Lausanne, Switzerland