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Taking people in ItalyPhase 1

Tests a radioactive drug in several advanced cancers

Tests a radioactive drug in adults with pancreatic, lung, breast or colorectal cancer.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Milan and Reggio Emilia, ItalySee the 2 sitesAlso in 9 other countries, 25 sites
Registry title
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Status
Recruiting
Phase
Phase 1
People taking part
162 people, planned
Started
15 Oct 2024
Expected to end
16 Jan 2031
Type of study
Interventional
Treatments tested
  • [68Ga]Ga-NNS309
  • [177Lu]Lu-NNS309
Record updated
29 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced pancreatic, lung, breast or colorectal cancer that cannot be removed by surgery or has spread, and that has worsened after earlier treatment.

Age
18 to 100 years
Sex
All sexes can join.
Disease stage
Locally advanced cancer that cannot be removed by surgery, or metastatic cancer. Types: pancreatic ductal adenocarcinoma, non-small cell lung cancer, HR+/HER2- ductal or lobular breast cancer, triple negative breast cancer, or colorectal cancer.
Earlier treatment
The cancer must have grown after, or the person could not tolerate, earlier treatment. Pancreatic and colorectal cancer: chemotherapy. Lung cancer: chemotherapy and immunotherapy, or targeted therapy if there is an actionable genomic alteration. Both breast cancer types: at least 2 lines of therapy. Colorectal cancer with MSI-H or dMMR status also needs immune checkpoint inhibitor therapy. Exceptions apply if the person was not able to receive these treatments.
Biomarker or test result
Tumour lesions must show 68Ga-NNS309 uptake on imaging.

Main reasons for not taking part

  • Low blood counts: ANC below 1.5 x 10^9/L, hemoglobin below 9 g/dL, or platelets below 100 x 10^9/L
  • QTcF of 470 msec or more on heart tracing
  • Estimated kidney filtration (eGFR) below 60 mL/min/1.73m2
  • Urinary tract blockage or urinary incontinence that cannot be managed
  • Radiation therapy within 4 weeks before the first dose

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Radiation therapy within 4 weeks prior to the first dose of [177Lu]Lu-NNS309; Other protocol-defined inclusion/exclusion criteria may apply
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in Italy

Also in 9 other countries, 25 sites

  • Milan, MIHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • Reggio Emilia, REHospital not named in the registryContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • Arm 1Treatment being tested

    Patients will receive \[68Ga\]Ga-NNS309, and if eligible, \[177Lu\]Lu-NNS309

    Treatment: [68Ga]Ga-NNS309 and [177Lu]Lu-NNS309

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests a radioactive drug in several advanced cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06562192, who can take part
Record updated
29 July 2026