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Study of Vobramitamab Duocarmazine and Prednisone for Patients with Metastatic Castration-Resistant Prostate Cancer

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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 a type of prostate cancer known as Metastatic Castration-resistant Prostate Cancer. This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is testing a new treatment called Vobramitamab Duocarmazine, which is an antibody-drug conjugate. This means it is a special type of medicine that combines an antibody with a drug to target and kill cancer cells more effectively. The trial will also use a medication called Prednisone, which is a steroid that can help reduce inflammation and support the body during cancer treatment.

The purpose of the study is to evaluate how effective Vobramitamab Duocarmazine is at two different dose levels in treating this type of prostate cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will compare the effects of the two dose levels to see which one works better in slowing down the progression of the cancer. Some participants may also receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatment.

Throughout the study, participants will be monitored regularly to assess how the cancer is responding to the treatment. This will involve various tests and scans, such as MRI or computed tomography (CT), to check for changes in the cancer. The study aims to provide valuable information on the potential benefits and safety of Vobramitamab Duocarmazine for patients with this challenging form of prostate cancer. The trial is expected to continue for a period of time to gather enough data to make informed conclusions about the treatment's effectiveness.

The research process

The trial runs in 4 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 will be conducted. This includes confirming the diagnosis of metastatic castration-resistant prostate cancer and ensuring there are no signs of specific cell features that are not allowed in the study.

    A review of recent imaging tests, such as MRI, CT, or bone scans, will be performed to confirm the presence of at least one metastatic lesion. These tests should have been completed within 28 days before starting the study treatment.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of vobramitamab duocarmazine. This medication is given as an intravenous infusion, meaning it is delivered directly into a vein.

    In addition to the infusion, prednisone tablets will be taken orally. The dosage and frequency of these medications will be specified by the study team.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the study, regular monitoring will occur to assess the effectiveness of the treatment. This includes tracking the progression of the cancer using imaging tests and measuring specific markers in the blood.

    Participants will be observed for any side effects or adverse reactions to the medications. Adjustments to the treatment plan may be made based on these observations.

  4. Step 4

    Completion of study

    The study is expected to continue until September 2026. Participants will be informed about the end of their involvement in the study and any follow-up procedures that may be necessary.

    Final assessments will be conducted to evaluate the overall outcomes of the treatment and its impact on the cancer.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of **adenocarcinoma of the prostate**. This means a specific type of prostate cancer that does not show certain rare features.
  • Must have at least one **metastatic lesion**. This is a cancer spot that has spread to other parts of the body, visible on an MRI, CT scan, or bone scan done within 28 days before starting the study treatment.
  • Must show **tumor progression** at the start of the study. This means the cancer is getting worse, as shown by a blood test called PSA or imaging tests.
  • Must have received one previous treatment called **ARAT** for prostate cancer. ARAT stands for Androgen Receptor Axis-Targeted therapy, which is a type of medication used to treat prostate cancer. A second short-term ARAT treatment is allowed if it was used to prepare for another treatment called lutetium-177.
  • Must provide a sample of the tumor tissue if the cancer has spread to internal organs. This sample can be from a previous biopsy or surgery.
  • Must be in an **acceptable physical condition** and have laboratory test results that are within a safe range.
  • Must be **male**.

Who cannot join the trial?

3 criteria

  • Patients who do not have **Metastatic Castration-resistant Prostate Cancer** cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Only **male** patients can participate.
  • Patients who are part of a **vulnerable population** cannot participate. This means groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Vobramitamab Duocarmazine is a medication being studied for its potential to treat prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. This medication is designed to target and bind to specific proteins on the surface of cancer cells. Once attached, it delivers a toxic substance directly into the cancer cells, which may help to stop their growth or kill them. The goal of using this medication in the trial is to see if it can help slow down the progression of the cancer as observed through imaging tests. Participants in the trial receive this medication to evaluate its effectiveness and safety in managing their condition.

What is already known about the treatment

Vobramitamab Duocarmazine – Vobramitamab duocarmazine is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer, a type of prostate cancer that continues to grow despite hormone therapy. This medication works by targeting specific proteins on cancer cells, delivering a toxic substance directly to them, which helps to kill the cancer cells while minimizing damage to normal cells. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Metastatic Castration-resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. It is characterized by the cancer's ability to metastasize, or spread, to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells become resistant to hormonal therapies that are typically used to control prostate cancer growth. Over time, the cancer may cause symptoms such as pain, urinary issues, and fatigue due to its spread and growth. The progression of the disease is often monitored through imaging tests and prostate-specific antigen (PSA) levels. As the cancer advances, it may lead to complications related to bone health and other systemic effects.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501078-20-00Protocol codeCP-MGC018-03Estimated enrolment120 patientsSponsorMacrogenics Inc.

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