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NCT06562192Recruiting

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

Official recordSimplified version

Summary

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).

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 • 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 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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 1
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, United States, Belgium, Canada, Israel, Netherlands, Spain
Sponsor
Novartis Pharmaceuticals(Industry)
Protocol no.
CFXX489A12101
Conditions
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer
Interventions
Drug

Treatments studied

  • [68Ga]Ga-NNS309
  • [177Lu]Lu-NNS309

Locations · 29

  • Geneva, SwitzerlandNovartis Investigative SiteRecruiting at this site
  • Lausanne, SwitzerlandNovartis Investigative SiteRecruiting at this site
  • Bron, FranceNovartis Investigative SiteRecruiting at this site
  • Villejuif, FranceNovartis Investigative SiteRecruiting at this site
  • Cologne, GermanyNovartis Investigative SiteRecruiting at this site
  • Essen, GermanyNovartis Investigative SiteRecruiting at this site
  • München, GermanyNovartis Investigative SiteRecruiting at this site
  • Rostock, GermanyNovartis Investigative SiteRecruiting at this site
  • Milan, ItalyNovartis Investigative SiteRecruiting at this site
  • Reggio Emilia, ItalyNovartis Investigative SiteRecruiting at this site
  • Birmingham, United StatesUni of Alabama at BirminghamRecruiting at this site
  • Los Angeles, United StatesUniversity of California LARecruiting at this site
  • Palo Alto, United StatesStanford University Medical CenterRecruiting at this site
  • Jacksonville, United StatesMayo Clinic JacksonvilleRecruiting at this site
  • Boston, United StatesMassachusetts General HospitalRecruiting at this site
  • Grand Rapids, United StatesBAMF HealthRecruiting at this site
  • Rochester, United StatesMayo Clinic RochesterRecruiting at this site
  • Houston, United StatesUni Of TX MD Anderson Cancer CntrRecruiting at this site
  • Seattle, United StatesUniversity Of WashingtonRecruiting at this site
  • Brussels, BelgiumNovartis Investigative SiteRecruiting at this site
  • Toronto, CanadaNovartis Investigative SiteRecruiting at this site
  • Montreal, CanadaNovartis Investigative SiteRecruiting at this site
  • Montreal, CanadaNovartis Investigative SiteRecruiting at this site
  • Tel Aviv, IsraelNovartis Investigative SiteRecruiting at this site
  • Nijmegen, NetherlandsNovartis Investigative SiteRecruiting at this site
  • Utrecht, NetherlandsNovartis Investigative SiteRecruiting at this site
  • Barcelona, SpainNovartis Investigative SiteRecruiting at this site
  • Madrid, SpainNovartis Investigative SiteRecruiting at this site
  • Madrid, SpainNovartis Investigative SiteRecruiting at this site

In total, worldwide, all 29 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: July 29, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2023-510356-23 · other identifier
  • 2023 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.