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Study on the Safety and Effects of [177Lu]-NeoB in Patients with Advanced Solid Tumors Overexpressing GRPR

Verified siteInvestigationalNo 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 focused on studying advanced solid tumors, which are types of cancer that form in solid organs or tissues. These tumors are known to have high levels of a specific protein called the gastrin-releasing peptide receptor (GRPR). The study is testing a new treatment called [177Lu]-NeoB, which is a solution given through an infusion into the veins. This treatment is designed to target and potentially reduce the size of these tumors. Another substance involved in the study is AAA503, which is used to prepare the treatment.

The purpose of the study is to evaluate the safety and effectiveness of [177Lu]-NeoB in patients with these advanced tumors. The study is divided into two phases. In the first phase, researchers aim to find the safest dose of the treatment. In the second phase, they will assess how well the treatment works in different types of solid tumors, such as breast cancer, lung cancer, prostate cancer, and others. Some patients will also receive a medication called a neprilysin inhibitor (NEPi) to see how it affects the distribution and activity of the treatment in the body.

Throughout the study, participants will receive the treatment and be monitored for any side effects and changes in their tumors. The study will also look at how the treatment spreads in the body and how it is processed. This research aims to provide valuable information on the potential benefits of [177Lu]-NeoB for patients with these challenging types of cancer.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include being an adult with specific types of advanced or metastatic solid tumors, such as breast, lung, or prostate cancer, among others.

  2. Step 2

    Treatment administration

    The treatment involves the administration of [177Lu]-NeoB, a solution for infusion given intravenously.

    The goal of Phase I is to determine the maximum tolerated dose and the recommended dose for Phase II.

    In Phase IIa, the focus is on assessing the anti-tumor activity of [177Lu]-NeoB at the recommended dose.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to evaluate the body's response to the treatment.

    This includes assessing the distribution of the treatment in the body, measuring radiation levels, and monitoring any side effects.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are performed to track the progress of the treatment and its impact on the tumor.

    These assessments help in understanding the effectiveness of the treatment and any changes in health status.

  5. Step 5

    Completion of trial

    Upon completion of the trial, a final evaluation is conducted to summarize the findings and the overall impact of the treatment.

    The trial is estimated to conclude by December 2026.

Who can join the trial?

9 criteria

  • Patients must sign a form to show they understand and agree to participate in the study.
  • Participants must be adults, aged 18 years or older, with certain types of advanced or spreading solid tumors. These include breast cancer, lung cancer, prostate cancer, gastrointestinal stromal tumors (GIST), and glioblastoma multiforme (GBM).
  • For Phase IIa, specific groups include:
    • Breast cancer with certain characteristics: hormone receptor-positive, HER-2 negative.
    • Prostate cancer.
    • GIST.
    • Any advanced solid tumor that shows high levels of a specific protein called GRPR, including recurrent GBM, and with moderately reduced kidney function.
    • Participants must have at least one tumor that can be measured using specific imaging techniques, and this tumor must show uptake of a special imaging agent called [68Ga]-NeoB.
    • Participants should not have any standard treatment options available, suitable, or tolerated. For breast cancer patients in Phase IIa, they must have tried at least one hormone therapy and one chemotherapy in the metastatic setting, unless not possible. They may also have had certain other treatments if applicable.
    • Participants must have a certain level of physical ability, measured by the Eastern Cooperative Oncology Group (ECOG) performance status. For Phase I, this should be 2 or less, and for Phase IIa, it should be 1 or less.

Who cannot join the trial?

9 criteria

  • Patients with solid tumors that do not have high levels of a specific protein called GRPR cannot participate. This protein is important for the study.
  • Patients whose tumors do not show uptake of a special imaging agent called [68Ga]-NeoB are excluded. This means the tumors do not absorb this agent, which is necessary for the study.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for specific age groups.
  • Patients who are not able to tolerate the study medication or have had severe reactions to similar treatments in the past are excluded.
  • Patients with certain medical conditions that could interfere with the study or make it unsafe for them to participate are not allowed.
  • Patients who are pregnant or breastfeeding cannot take part in the study, as it may affect the baby.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are excluded to ensure their safety.
  • Patients who are currently participating in another clinical trial or have recently participated in one may not be eligible.
  • Patients who have not fully recovered from previous treatments or surgeries may be excluded to ensure they are healthy enough for the study.
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Investigated drugs

  • [177Lu]-NeoB

    is a medication being studied for its potential to treat advanced solid tumors that have a high level of a specific protein called gastrin-releasing peptide receptor (GRPR). This medication is designed to target and deliver radiation directly to the cancer cells, which may help to reduce or eliminate the tumors.

  • LCZ696

    is a neprilysin inhibitor that is used in combination with [177Lu]-NeoB in this study. Its role is to potentially enhance the effectiveness of [177Lu]-NeoB by affecting how the medication is distributed throughout the body and how it interacts with the tumors. This combination is being specifically tested in certain locations like the US and UK.

What is already known about the treatment

[177Lu]-NeoB – This medication is administered intravenously and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating advanced solid tumors that overexpress the gastrin-releasing peptide receptor (GRPR). It is in the early phases of clinical research, with ongoing studies to determine the optimal dosage and assess its anti-tumor activity. The main therapeutic indication is for solid tumors with specific receptor characteristics. At the molecular level, [177Lu]-NeoB works by targeting and binding to GRPR, delivering a radioactive payload directly to the cancer cells, which helps to destroy them. It is classified as a radiopharmaceutical, a type of drug that combines a radioactive element with a targeting molecule.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones, and are characterized by the uncontrolled growth of cells. These tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they can invade nearby tissues and spread to other areas. The progression of solid tumors depends on their type and location, as well as the rate at which the tumor cells grow and divide. Over time, malignant solid tumors may develop the ability to metastasize, spreading cancer cells to distant parts of the body. The specific behavior and growth rate of solid tumors can vary widely, influencing how they affect the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-507170-41-00Protocol codeCAAA603A12101Estimated enrolment51 patientsSponsorAdvanced Accelerator Applications International S.A.

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