Study Description
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 ≥ 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). 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 at least 80% of the 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.
Interventions
[177Lu]Lu-NNS309
[68Ga]Ga-NNS309
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Patients with one of the following indications:
- Locally advanced unresectable or metastatic PDAC who have received prior treatment
with at least 1 line of cytotoxic chemotherapy, unless patient was ineligible to
receive such therapy
- Locally advanced unresectable or metastatic NSCLC without any actionable genomic
alterations who have received prior treatment with chemotherapy and immunotherapy,
unless patient was ineligible to receive such therapy, or locally advanced
unresectable or metastatic NSCLC with an actionable genomic alteration who have
received prior treatment with 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
- Locally advanced unresectable or metastatic TNBC with disease progression following,
or intolerance to, at least 2 lines of therapy
- (Dose escalation part only) Locally advanced or metastatic unresectable CRC who have
received prior therapy with at least 1 line of 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
received 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 < 10 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 Location
Novartis Investigative Site
Recruiting
Tel Aviv,6423906,Israel
Worldwide Contacts
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