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Study of AMO959, lutetium (177Lu) vipivotide tetraxetan, and a drug combination for adults with advanced prostate cancer.

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What is this trial about?

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

This study focuses on treating metastatic castration-resistant prostate cancer, a type of prostate cancer that has spread to other parts of the body and continues to grow even after hormone therapy. The participants in this study have a specific marker on their cancer cells called PSMA. The purpose of the study is to investigate the safety and effectiveness of combining a new drug called AMO959 with lutetium (177Lu) vipivotide tetraxetan and an androgen receptor pathway inhibitor, which is a type of medication used to block hormones that help cancer grow. Other medications, such as abiraterone or enzalutamide, may also be used as part of the treatment plan.

The study is being conducted in two stages. The first stage focuses on finding the correct dose of AMO959 that can be given safely alongside the other treatments. The second stage looks at how well this combination of medicines works to control the cancer. During the study, researchers will monitor how the body responds to the treatment and check for any side effects. They will also look at changes in PSA, which is a protein used as a marker to track the activity of prostate cancer in the blood.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in phase ib

    During the phase ib stage, the primary focus is to determine the safety and how well the body tolerates the combination of AMO959, lutetium (177Lu) vipivotide tetraxetan (also known as AAA617), and an androgen receptor pathway inhibitor (an ARPI, which is a type of medication used to treat prostate cancer).

  2. Step 2

    Participation in phase ii

    During the phase ii stage, the study focuses on evaluating how effective the combination of AMO959, AAA617, and an ARPI is in treating the cancer.

  3. Step 3

    Medication administration

    The treatment involves taking AMO959 in the form of a capsule.

    The treatment also includes lutetium (177Lu) vipivotide tetraxetan (AAA617), which is administered through an intravenous injection or infusion (a liquid delivered directly into a vein).

    An androgen receptor pathway inhibitor (ARPI) is also used. This may include medications such as enzalutamide (taken as a capsule or soft capsule) or abiraterone (taken as a tablet).

Who can join the trial?

10 criteria

  • You must provide a signed informed consent, which is a written document where you agree to participate in the study after understanding all the details.
  • You must be an adult, aged 18 years or older.
  • You must have an ECOG performance status of 0 to 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • Your diagnosis must be adenocarcinoma of the prostate, which is the most common type of prostate cancer, confirmed through a laboratory examination of tissue. Other types of prostate cancer are not allowed.
  • For the first part of the study, you may have had one previous treatment with taxane-based chemotherapy, which is a type of medicine used to kill cancer cells. For the second part, you must not have used this specific type of chemotherapy for your advanced prostate cancer.
  • Your cancer must show PSMA-PET positivity, meaning a special type of imaging scan has detected a specific protein on your cancer cells that the scan can target.
  • You must have castration-level testosterone (meaning very low levels of the hormone testosterone, less than 50 ng/dL) and/or be using androgen deprivation therapy (ADT), which is a treatment used to lower the hormone levels that help prostate cancer grow.
  • You must have metastatic castration-resistant prostate cancer (mCRPC), which is a stage where the cancer has spread to other parts of the body and no longer responds to hormone therapy.
  • Your cancer must have shown progressive disease while you were taking an ARPI (an androgen receptor pathway inhibitor, a type of hormone therapy), meaning the cancer grew or spread despite the treatment.
  • Progression can be shown by a rise in PSA (prostate-specific antigen), which is a protein found in the blood that can indicate how much prostate cancer is present, or by the appearance of new soft-tissue or bone lesions (new areas of cancer growth) on medical scans.

Who cannot join the trial?

11 criteria

  • You are not a male.
  • You are not within the required age range (between 18 and 65 years old).
  • You are currently receiving radiation therapy to the prostate intended to cure the disease, or other procedures meant to destroy cancer cells in the prostate.
  • You are currently receiving systemic treatments, which are medicines that travel through the whole body, such as hormonal ablation (drugs that stop hormones), chemotherapy (drugs used to kill cancer cells), immunotherapy (treatments that help the immune system fight cancer), or radioligand therapies (RLTs) (treatments that use radioactive substances to target cancer).
  • You have received any of the treatments mentioned above within 28 days of starting the study.
  • You have previously used any radioligand therapy (RLT) or PSMA-targeted agents (medicines specifically designed to find and attack a protein found on certain cancer cells).
  • You have used any other investigational agents (drugs that are still being tested and are not yet widely available) within 28 days before the first dose of the study treatment.
  • You have any other serious medical conditions that could make it difficult to complete the study steps or follow-up appointments.
  • You have a history of CNS metastases (cancer that has spread to the central nervous system, which includes the brain and spinal cord) and have not received treatment such as surgery, whole brain radiation therapy, or stereotactic radiosurgery (a highly precise form of radiation).
  • You have a history of cancer in the brain but are not neurologically stable (meaning your brain and nerve functions are steady and not worsening) or are still experiencing symptoms.
  • You are taking corticosteroids (a type of steroid medicine used to reduce swelling or inflammation) specifically to keep your nervous system functioning correctly.
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Investigated drugs

  • AMO959

    is an experimental drug that acts as a DNA protein kinase inhibitor, which is being studied to see how well it works when combined with other treatments for prostate cancer.

  • Enzalutamide

    is a medication known as an androgen receptor pathway inhibitor that works by blocking the effects of male hormones that can help prostate cancer grow.

  • Lutetium (177Lu) vipivotide tetraxetan

    is a targeted therapy delivered through an IV that uses a radioactive substance to find and attack specific cells in the body related to prostate cancer.

  • Abiraterone

    is a medication used to treat prostate cancer by reducing the amount of male hormones the body produces.

What is already known about the treatment

  • AMO959

    This investigational drug is administered as a capsule for various uses and is currently being studied in clinical trials. It is designed to target and inhibit DNA protein kinase, a specific molecule that helps cancer cells repair their genetic material. As a DNA protein kinase inhibitor, it aims to prevent cancer cells from repairing themselves, making them more vulnerable to treatment.

  • Enzalutamide

    This medication is taken orally in the form of soft capsules to treat advanced prostate cancer. It belongs to a group of drugs called androgen receptor pathway inhibitors that work by blocking the hormone receptors on cancer cells. By preventing these receptors from receiving signals from male hormones, the drug stops the cancer cells from growing and multiplying.

  • Prednisone

    This is an established medication taken orally in tablet form to manage various inflammatory conditions and cancer-related symptoms. It belongs to a class of drugs known as corticosteroids, which work by reducing swelling and calming the body's immune response. In this context, it is often used to help manage side effects or support other cancer treatments.

  • Degarelix

    This substance is used in medical settings to treat advanced prostate cancer, typically through administration methods such as injections. It is classified as a gonadotropin-releasing hormone analogue that works by temporarily shutting down the production of hormones in the body. This reduction in hormone levels helps to starve prostate cancer cells of the signals they need to grow.

  • Relugolix

    This medication is used to treat prostate cancer by managing the hormones that drive the disease. It belongs to a class of drugs called luteinizing hormone-releasing hormone agonists that work by blocking the signals that tell the body to produce testosterone. By lowering these hormone levels, the drug helps to slow down the progression of the cancer.

  • Lutetium (177Lu) vipivotide tetraxetan

    This specialized treatment is administered intravenously as a solution for injection or infusion to treat certain types of advanced prostate cancer. It is a radiopharmaceutical that works by attaching to a specific protein found on the surface of cancer cells and delivering targeted radiation directly to them. This molecular approach allows the radiation to destroy the cancer cells while minimizing damage to surrounding healthy tissue.

Investigated diseases

Metastatic castration-resistant prostate cancer - This is an advanced stage of prostate cancer that continues to grow even when testosterone levels are lowered through medical treatments. The cancer cells develop ways to grow despite the absence of male hormones. It often involves the spread of cancer cells to other parts of the body, such as the bones. The disease can progress by becoming less responsive to standard hormone therapies. In some cases, the cancer cells increase the expression of certain proteins on their surface, which can be detected through specific imaging.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521859-23-00Protocol codeCAMO959A12103Estimated enrolment123 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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