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Study of Lorigerlimab and Docetaxel 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 male hormones in the body is reduced to very low levels. The study is investigating the effects of a new treatment combination involving a medication called Lorigerlimab and another drug named Docetaxel, compared to using Docetaxel alone. Lorigerlimab is a type of protein designed to help the immune system fight cancer by targeting specific proteins on cancer cells.

The purpose of the study is to evaluate how effective the combination of Lorigerlimab and Docetaxel is in treating this type of prostate cancer. Participants in the study will be randomly assigned to receive either the combination of Lorigerlimab and Docetaxel or Docetaxel alone. The study will monitor the participants over a period to see how the cancer responds to the treatment. This includes checking if the cancer stops growing or shrinks, and how long it takes for the cancer to start growing again. The study will also look at the overall health and survival of the participants, as well as any side effects they may experience.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the progress of the cancer. These tests may include imaging scans and blood tests to measure the levels of prostate-specific antigen (PSA), a substance often found in higher amounts in men with prostate cancer. The study aims to provide valuable information on whether the new treatment combination can offer better outcomes for patients with Metastatic Castration-Resistant Prostate 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to prostate cancer progression and previous treatments.

    Participants must have a type of prostate cancer that has spread and is resistant to standard hormone therapy.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either a combination of lorigerlimab and docetaxel or docetaxel alone.

    The purpose is to compare the effectiveness of the combination treatment against the standard treatment.

  3. Step 3

    Medication administration

    Docetaxel is administered as a solution for infusion, which means it is given through a vein.

    Lorigerlimab is also administered intravenously, as a concentrate for solution for infusion.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment, including imaging tests to evaluate cancer progression.

    Blood tests and other assessments are performed to monitor health and any side effects.

  5. Step 5

    Completion of treatment

    The study continues until the estimated end date in September 2027, or until specific criteria for stopping treatment are met.

    Participants are followed up to evaluate long-term outcomes and any lasting effects of the treatment.

Who can join the trial?

8 criteria

  • The patient must have **metastatic castration-resistant adenocarcinoma of the prostate**. This means the prostate cancer has spread to other parts of the body and is not responding to treatments that lower testosterone.
  • The cancer should not show signs of **neuroendocrine differentiation**, **signet cell**, or **small cell features**. These are specific types of cancer cell changes that are not allowed in this study.
  • The patient must have at least one **metastatic lesion**. This means there is at least one area where the cancer has spread, which can be measured or identified by doctors.
  • The patient must show **prostate cancer progression** at the start of the study. This means the cancer is getting worse according to specific criteria used by doctors.
  • The patient must have evidence of the disease getting worse after trying at least one previous treatment that targets the **androgen receptor axis**. This includes medications like abiraterone, enzalutamide, apalutamide, or darolutamide.
  • If the patient has a known history of a **BRCA gene mutation**, they must have already received a treatment called a **PARP inhibitor**.
  • The patient must have an adequate **performance status**, which means they are well enough to participate in the study, along with a reasonable **life expectancy** and acceptable **laboratory values**. These are basic health checks to ensure the patient can safely take part in the trial.
  • Only male patients are eligible to participate in this study.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer other than Metastatic Castration-Resistant Prostate Cancer. This is a specific type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Patients who are female. This study is only for male patients.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like those who cannot make decisions for themselves.
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Investigated drugs

  • Lorigerlimab

    is an investigational medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients with this type of cancer.

  • Docetaxel

    is a chemotherapy drug commonly used to treat various types of cancer, including prostate cancer. In this study, it is used both alone and in combination with lorigerlimab to determine its effectiveness in treating metastatic castration-resistant prostate cancer.

What is already known about the treatment

  • Lorigerlimab

    Lorigerlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic castration-resistant prostate cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for lorigerlimab is to potentially improve outcomes in prostate cancer that has spread and is resistant to hormonal therapy. At the molecular level, lorigerlimab works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. It is classified as an immunotherapy agent.

  • Docetaxel

    Docetaxel is administered intravenously and is a well-established chemotherapy medication used in the treatment of various cancers, including metastatic castration-resistant prostate cancer. It is widely recognized in medical literature and is part of standard cancer treatment protocols. The main therapeutic indication for docetaxel is to slow or stop the growth of cancer cells. At the molecular level, docetaxel works by interfering with the microtubule structures within the cell, which are essential for cell division, thereby inhibiting cancer cell proliferation. It is classified as a taxane-based chemotherapy agent.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have adapted to survive in a low-testosterone environment, making them resistant to traditional hormone therapy. The disease often progresses by spreading to bones and other organs, leading to various symptoms such as pain and difficulty with urination. Over time, the cancer may cause significant discomfort and impact daily activities. The progression of this disease is typically monitored through imaging tests and blood markers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502982-49-00Protocol codeCP-MGD019-02Estimated enrolment150 patientsSponsorMacrogenics Inc.

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