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Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
NCT06562192 · Novartis
In plain English
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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
About this study
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
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
* (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:
* 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.
Study design
Enrollment target: 162 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-15
Estimated completion: 2031-01-16
Last updated: 2026-04-08
Interventions
Drug: [68Ga]Ga-NNS309Drug: [177Lu]Lu-NNS309
Primary outcomes
- • Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 (From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule)
- • Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309 (From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months)
- • Dose modifications for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
All locations (31)
Uni of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of California LARecruiting
Los Angeles, California, United States
Stanford University Medical CenterRecruiting
Palo Alto, California, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
BAMF HealthRecruiting
Grand Rapids, Michigan, United States
BAMF HealthRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Uni Of TX MD Anderson Cancer CntrRecruiting
Houston, Texas, United States
University Of WashingtonRecruiting
Seattle, Washington, United States
Novartis Investigative SiteRecruiting
Brussels, Belgium
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Bron, France
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Villejuif, France
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Cologne, North Rhine-Westphalia, Germany
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Essen, Germany
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München, Germany
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Rostock, Germany
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Tel Aviv, Israel
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Milan, MI, Italy
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Reggio Emilia, RE, Italy
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Nijmegen, Gelderland, Netherlands
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Utrecht, Netherlands
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Geneva, Switzerland
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Lausanne, Switzerland