Status:
RECRUITING
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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 ...
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-NN...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 16 2031
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06562192
Start Date
October 15 2024
End Date
January 16 2031
Last Update
December 16 2025
Active Locations (27)
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1
University of California LA
Los Angeles, California, United States, 90095
2
Stanford University Medical Center
Palo Alto, California, United States, 94304
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114