Skip to content
TrialMatch
Sign up
Recruiting Phase 1

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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).

Condition
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer
Tested
[68Ga]Ga-NNS309, [177Lu]Lu-NNS309
Sponsor
Novartis Pharmaceuticals

Who can join

Age
18 to 100 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Maximum age: 100 years
  • Study condition: Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer
  • 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 6

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply.

Where

29 sites, 29 recruiting

Novartis Investigative Site

Brussels, Belgium

Recruiting

Novartis Investigative Site

Montreal, Quebec, Canada

Recruiting

Novartis Investigative Site

Montreal, Quebec, Canada

Recruiting

Novartis Investigative Site

Toronto, Ontario, Canada

Recruiting

Novartis Investigative Site

Bron, France

Recruiting

Novartis Investigative Site

Villejuif, France

Recruiting

and 23 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.