Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Recruiting · NCT06562192 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
[177Lu]Lu-NNS309[68Ga]Ga-NNS309
What this trial is about
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).
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
29 locations listed across 8 US states.
- 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
- 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 - Barcelona, Spain
- Novartis Investigative Site - Bron, France
- Novartis Investigative Site - Brussels, Belgium
- Novartis Investigative Site - Essen, Germany
- Novartis Investigative Site - Geneva, Switzerland
- Novartis Investigative Site - Lausanne, Switzerland
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - München, Germany
- Novartis Investigative Site - Rostock, Germany
- Novartis Investigative Site - Tel Aviv, Israel
- Novartis Investigative Site - Utrecht, Netherlands
- Novartis Investigative Site - Villejuif, France
- Novartis Investigative Site - Nijmegen, Gelderland, Netherlands
- Novartis Investigative Site - Milan, MI, Italy
- Novartis Investigative Site - Cologne, North Rhine-Westphalia, Germany
- Novartis Investigative Site - Toronto, Ontario, Canada
- Novartis Investigative Site - Montreal, Quebec, Canada
- Novartis Investigative Site - Montreal, Quebec, Canada
- Novartis Investigative Site - Reggio Emilia, RE, Italy