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RecruitingPhase 1

Phase I Study of [177Lu]Lu-NNS309 in Patients With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In both parts of the study, patients will initially be imaged with a \[68Ga\]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for \[177Lu\]Lu-NNS309 treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, side effects, radiation dose, and early signs of cancer control with [177Lu]Lu-NNS309. It also tests the safety, radiation dose, and scan images of [68Ga]Ga-NNS309. It is for adults with certain pancreatic, lung, breast, or colorectal cancers that have grown nearby or spread.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old.
  • You must have one of the cancer types below that has grown nearby and cannot be removed by surgery, or has spread. The colorectal cancer must not be removable by surgery.
  • Pancreatic ductal cancer: chemotherapy stopped working or caused side effects you could not tolerate, or you could not receive it.
  • Non-small cell lung cancer: if there is no gene change that can be targeted with medicine, chemotherapy and immune treatment stopped working or were not tolerated. If there is such a gene change, targeted treatment stopped working or was not tolerated. You may also qualify if you could not receive these treatments.
  • HR-positive, HER2-negative ductal or lobular breast cancer, or triple-negative breast cancer: at least two rounds of different treatments stopped working or were not tolerated, or you could not receive them. These labels describe hormone receptors and a protein on cancer cells.
  • Colorectal cancer: chemotherapy stopped working or was not tolerated, or you could not receive it. If your cancer has certain DNA repair problems called MSI-H or dMMR, immune checkpoint treatment must also have stopped working, been intolerable, or not been an option.
  • Your tumors must take up [68Ga]Ga-NNS309 on a scan.

Who can't join

  • Blood counts below any of these levels: neutrophils, which fight infection, 1.5 × 10^9/L; hemoglobin, which carries oxygen, 9 g/dL; or platelets, which help blood clot, 100 × 10^9/L.
  • A heart test shows a corrected QT interval of 470 milliseconds or more. This measures part of the heart's electrical timing.
  • Estimated kidney filtering rate below 60 mL/min/1.73 m².
  • A blockage in urine flow or urine leakage that cannot be managed.
  • Radiation treatment within 4 weeks before the first dose of [177Lu]Lu-NNS309.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 * 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.

Study sites (9)

AL

CA

FL

MA

MI

MN

TX

WA