Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Start Date
10/15/2024
Completion Date
1/16/2031
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).
Detailed Description
The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a \[68Ga\]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for \[177Lu\]Lu-NNS309 treatment. In the escalation part, different doses of \[177Lu\]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of \[177Lu\]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
[68Ga]Ga-NNS309
[177Lu]Lu-NNS309
Conditions
Locations
Uni of Alabama at Birmingham
Birmingham, Alabama 35249
United States
University of California LA
Los Angeles, California 90095
United States
Stanford University Medical Center
Palo Alto, California 94304
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
BAMF Health
Grand Rapids, Michigan 49503
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas 77030
United States
University Of Washington
Seattle, Washington 98109
United States
Novartis Investigative Site
Brussels, 1000
Belgium
Novartis Investigative Site
Toronto, Ontario M5G 2M9
Canada
Novartis Investigative Site
Montreal, Quebec H2X 1R9
Canada
Novartis Investigative Site
Montreal, Quebec H3T 1E2
Canada
Novartis Investigative Site
Bron, 69677
France
Novartis Investigative Site
Villejuif, 94800
France
Novartis Investigative Site
Cologne, North Rhine-Westphalia 50937
Germany
Novartis Investigative Site
Essen, 45147
Germany
Novartis Investigative Site
München, 80377
Germany
Novartis Investigative Site
Rostock, 18057
Germany
Novartis Investigative Site
Tel Aviv, 6423906
Israel
Novartis Investigative Site
Milan, MI 20133
Italy
Novartis Investigative Site
Reggio Emilia, RE 42123
Italy
Novartis Investigative Site
Nijmegen, Gelderland 6500HB
Netherlands
Novartis Investigative Site
Utrecht, 3584 CX
Netherlands
Novartis Investigative Site
Barcelona, 08036
Spain
Novartis Investigative Site
Madrid, 28009
Spain
Novartis Investigative Site
Madrid, 28040
Spain
Novartis Investigative Site
Geneva, 1211
Switzerland
Novartis Investigative Site
Lausanne, 1011
Switzerland