Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
NCT ID: NCT06562192
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
162 participants
INTERVENTIONAL
2024-10-15
2031-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Patients will receive \[68Ga\]Ga-NNS309, and if eligible, \[177Lu\]Lu-NNS309
[68Ga]Ga-NNS309
Radioligand imaging agent
[177Lu]Lu-NNS309
Radioligand therapy
Interventions
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[68Ga]Ga-NNS309
Radioligand imaging agent
[177Lu]Lu-NNS309
Radioligand therapy
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Essen, , 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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2023-510356-23
Identifier Type: OTHER
Identifier Source: secondary_id
CFXX489A12101
Identifier Type: -
Identifier Source: org_study_id
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