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Evaluating a new treatment for advanced pancreatic, lung, breast, and colorectal cancers

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

Phase 1 Interventional Novartis · NCT06562192

This study is testing a new type of radiation treatment for people with advanced pancreatic, lung, breast, and colorectal cancers to see if it is safe and effective.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment162 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, Radiation
Locations31 sites (Birmingham, Alabama and 30 other locations)
Trial IDNCT06562192 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, and preliminary efficacy of a radioligand therapy called [177Lu]Lu-NNS309 in patients with advanced or metastatic cancers, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and various types of breast and colorectal cancers. The study is divided into two parts: an escalation phase to determine the recommended doses of the treatment and an expansion phase to further evaluate its safety and effectiveness. Patients will undergo imaging with [68Ga]Ga-NNS309 to assess eligibility before receiving treatment. The trial will follow participants for up to 36 months to monitor disease progression and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic pancreatic, lung, breast, or colorectal cancers that have progressed after standard therapies.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are difficult to treat.

How similar studies have performed: Other studies using radioligand therapy have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerHR+/HER2- Ductal and Lobular Breast CancerTriple Negative Breast CancerColorectal Cancerpancreatic ductal adenocarcinomanon-small cell lung cancerbreast cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.