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Study of 177Lu-FAP-2286 alone and with drug combinations for patients with advanced solid tumors including non-small cell lung cancer, breast cancer, and pancreatic cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is investigating treatments for patients with advanced solid tumors, specifically focusing on non-small cell lung cancer, breast cancer, and pancreatic ductal adenocarcinoma that has spread or cannot be removed by surgery. The study uses several medications including AAA614, paclitaxel, oxaliplatin, irinotecan, calcium folinate, and fluorouracil. Some of these drugs are combined into a treatment known as mFOLFIRINOX.

The study aims to test how well patients respond to these treatments and determine the safest and most effective doses. The main treatment being studied is a radioactive drug called [177Lu]Lu-FAP-2286, which will be given either alone or in combination with other cancer medications. This drug works by targeting specific proteins found in cancer cells.

During the study, patients will receive their assigned treatments through intravenous infusion, which means the medications are given directly into a vein. Doctors will monitor patients' responses to treatment and track any side effects that may occur. The study includes different treatment groups depending on the type of cancer and previous treatments patients have received.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your eligibility will be confirmed through laboratory tests to check bone marrow function, liver function, and kidney function

    A physical examination will be performed to assess your overall health status and confirm your ECOG performance status is 0 or 1 (ability to carry out daily activities)

    Your tumor measurements will be taken using CT or MRI scans to confirm presence of measurable disease

  2. Step 2

    Treatment administration - Imaging agent

    You will receive an intravenous injection of [68Ga]Ga-FAP-2286, an imaging agent to assess your tumor

  3. Step 3

    Treatment administration - Main therapy

    Based on your cancer type, you will receive one of the following treatment combinations via intravenous infusion:

    For pancreatic cancer: [177Lu]Lu-FAP-2286 combined with mFOLFIRINOX (combination of fluorouracil, calcium folinate, irinotecan, and oxaliplatin)

    For lung cancer: [177Lu]Lu-FAP-2286 combined with paclitaxel

    For breast cancer: [177Lu]Lu-FAP-2286 alone

  4. Step 4

    Monitoring during treatment

    Regular assessments will track your response to treatment using CT or MRI scans

    Blood tests will be performed to monitor your organ function

    Any side effects will be recorded and monitored

    Treatment will continue until disease progression or other stopping criteria are met

  5. Step 5

    End of treatment assessment

    Final scans will be performed to assess your response to treatment

    Final blood tests and physical examination will be conducted

    Any ongoing side effects will be documented

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must sign an informed consent form before any study procedures
  • Must have one of these confirmed cancers:
    • Recurring or spreading non-small cell lung cancer
    • Breast cancer that has spread
    • Pancreatic cancer that cannot be surgically removed or has spread
    • Must have adequate organ function, including:
      • Good bone marrow function
      • Proper liver function
      • Good kidney function
      • Must have a good physical condition (ECOG score of 0 or 1, which means able to do light work)
      • Must have a life expectancy of at least 6 months
      • Must have measurable tumors that are at least:
        • 10 millimeters for regular tumors
        • 15 millimeters for affected lymph nodes
        • Must agree to provide tumor tissue samples if available
        • For breast cancer patients: Must have received previous treatments depending on cancer type
        • For pancreatic cancer patients: Must have had 1-2 previous chemotherapy treatments
        • For lung cancer patients: Must have had previous chemotherapy and immunotherapy treatments

Who cannot join the trial?

13 criteria

  • Prior history of allergic reactions to study medications or similar substances
  • Pregnant or breastfeeding women
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • Serious heart conditions including heart failure or uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study
  • Current participation in other clinical trials
  • Severe kidney or liver problems
  • Active infections requiring treatment
  • History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to follow study procedures or attend scheduled visits
  • History of organ transplantation
  • Psychiatric illness or substance abuse that could interfere with the study
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Investigated drugs

Based on the provided trial information, here are the medications involved: Lu FAP-2286 is a radioactive medication used to target and treat advanced solid tumors. It contains lutetium-177, which delivers targeted radiation therapy to cancer cells. mFOLFIRINOX is a combination chemotherapy treatment that includes multiple cancer-fighting drugs used together to treat pancreatic cancer (PDAC). Nab-paclitaxel is a chemotherapy medication that is bound to protein particles, used to treat non-small cell lung cancer (NSCLC). It works by stopping cancer cells from dividing and growing.

What is already known about the treatment

  • [177Lu]Lu-FAP-2286

    A novel radiopharmaceutical therapy administered intravenously that combines lutetium-177 with a fibroblast activation protein (FAP) targeting molecule. This investigational treatment is currently being studied in clinical trials for patients with advanced solid tumors, including non-small cell lung cancer, breast cancer, and pancreatic ductal adenocarcinoma. The medication works by delivering targeted radiation therapy to cancer cells expressing FAP, a protein commonly found in the microenvironment of many solid tumors, while minimizing exposure to healthy tissues. It belongs to the class of targeted radiopharmaceuticals and represents an emerging approach in precision oncology.

  • mFOLFIRINOX

    A combination chemotherapy regimen administered intravenously that consists of modified doses of fluorouracil, leucovorin, irinotecan, and oxaliplatin. This established treatment protocol is commonly used in advanced pancreatic cancer therapy, working through multiple mechanisms to inhibit cancer cell division and growth. The medication belongs to the multi-agent chemotherapy class and acts by targeting different aspects of cancer cell metabolism and DNA replication.

  • Nab-paclitaxel

    An injectable form of paclitaxel bound to albumin nanoparticles, making it more easily delivered to cancer cells. This medication is approved for treating various types of cancer, including non-small cell lung cancer, and works by preventing cancer cell division through disruption of the microtubule network essential for cell division. It belongs to the taxane class of chemotherapy drugs and demonstrates enhanced tumor targeting compared to conventional paclitaxel formulations.

Investigated diseases

  • Non-small Cell Lung Cancer (NSCLC)

    A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. It develops when lung cells begin to grow abnormally and form tumors. NSCLC accounts for most lung cancer cases and typically grows and spreads more slowly than small cell lung cancer.

  • Breast Carcinoma (BC)

    A cancer that forms in the cells of the breast tissue. It occurs when breast cells begin to grow uncontrollably, forming a tumor that can be felt as a lump or seen on imaging. The cancer can develop in different parts of the breast and may spread to surrounding tissues.

  • Pancreatic Ductal Adenocarcinoma (PDAC)

    A cancer that develops in the ducts of the pancreas, which are tubes that carry digestive enzymes. It begins when cells in the pancreatic ducts start to grow uncontrollably. PDAC is the most common type of pancreatic cancer and affects the organ's ability to produce digestive enzymes and hormones.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508995-12-01Protocol codeCAAA614A12101Estimated enrolment156 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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