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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Uni of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of California LA
  Los Angeles, California, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• BAMF Health
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted radioligand [177Lu]Lu-DFC413 for advanced pancreatic, lung, breast, and colorectal cancers

  This will test a new targeted radioactive medicine, [177Lu]Lu-DFC413 (with a PET tracer [68Ga]Ga-NNS309), to see if it is safe and shows activity in adults with advanced pancreatic, lung, breast, or colorectal cancer.

  Recruiting at 9 sites Phase 1 Novartis · Princeton, New Jersey and 8 other locations · NCT07261631

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• First-in-human test of HH160 in people with advanced solid tumors

  HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.

  Recruiting at 3 sites Phase 1 Huahui Health · Waratah, New South Wales and 2 other locations · NCT07623369

• IBI3028 in advanced solid tumors

  This phase 1 study tests IBI3028 in adults with unresectable or metastatic solid tumors to see if it is safe and how patients tolerate it.

  Recruiting Phase 1 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Tianjin, Tianjin Municipality · NCT07589205

• IDE034 for adults with advanced solid tumors that express B7-H3 and PTK7

  This trial will test IDE034 to see if it is safe and works in adults with advanced or metastatic solid tumors that express B7-H3 and PTK7.

  Recruiting at 26 sites Phase 1 IDEAYA Biosciences · Duarte, California and 25 other locations · NCT07503808

• Finding a suitable dose of ASP5834 for adults with solid tumors

  This trial tests different doses of the experimental drug ASP5834, given alone or with panitumumab, in adults whose advanced solid tumors have certain KRAS mutations to find a safe, tolerable dose.

  Recruiting at 22 sites Phase 1 Astellas Pharma Inc · Santa Monica, California and 21 other locations · NCT07094204

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.