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A study testing the safety and effectiveness of AZD0516 alone and with other cancer drugs in adults with metastatic 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 involves people with metastatic prostate cancer, which means the cancer has spread from the prostate to other parts of the body. The study will test a medicine called AZD0516, which is given through a vein as an infusion, and another medicine called AZD9574, which is taken by mouth as a tablet. These medicines will be tested either alone or together with other cancer treatments. AZD0516 is an antibody-drug conjugate, which is a type of medicine that combines an antibody with a cancer-fighting drug. AZD9574 is a medicine that can reach the brain and works by blocking certain proteins called PARP1 that help cancer cells repair themselves.

The purpose of this study is to find out if these medicines are safe, how well they are tolerated by the body, and whether they can help fight the cancer. The study will also look at how the body processes these medicines and what effects they have on tumor growth. Doctors will measure a substance in the blood called PSA, which is a marker often used to monitor prostate cancer, to see if the treatment is working. They will also use imaging scans to check if the tumors are getting smaller or stopping their growth.

The study is divided into different parts. In the first part, different doses of the medicines will be tested to find the safest and most effective amount to give. In the second part, doctors will further test the chosen doses to see how well they work against the cancer. In the final part, the study will focus on checking how effective the treatment is in a larger group of people. Throughout the study, participants will have regular check-ups including blood tests, physical examinations, and scans to monitor their health and how the cancer is responding to treatment. Participants must have already received standard treatments for their prostate cancer or have a reason why standard treatments are not suitable for them.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Screening and baseline assessment
Before starting treatment, your medical history and current health status will be assessed to confirm eligibility for the trial.
A tumor tissue sample will be required. This can be from an existing archived sample or a newly obtained sample.
Blood tests will be performed to check organ function, including liver, kidneys, and bone marrow. Your testosterone level must be measured and confirmed to be at or below 50 ng/dL.
Your PSA level (a protein produced by the prostate) will be measured and must be at least 1 ng/mL.
Imaging scans such as CT scan, MRI, or bone scan will be performed to confirm the presence of cancer that has spread beyond the prostate to other parts of the body.
Your general physical condition will be evaluated using the ECOG performance status scale, which measures how the disease affects daily living abilities. Your score must be 0 or 1, meaning you are fully active or restricted only in physically strenuous activity.
An electrocardiogram (ECG) will be performed to check your heart's electrical activity.
Vital signs including blood pressure, heart rate, and temperature will be recorded.
If you have not had surgical removal of both testicles, you must continue androgen deprivation therapy (hormone treatment to lower testosterone) throughout the study. This treatment must have been started at least 2 weeks before joining the trial.
Step 2
Treatment phase
You will receive AZD0516, which is the investigational medication being tested in this trial. This medication may be given as monotherapy (alone) or in combination with other anti-cancer agents.
The medication will be administered either orally as film-coated tablets or intravenously (through a vein) as a solution for injection or infusion, depending on which part of the study you are enrolled in.
The specific dose, frequency, and duration of treatment will be determined based on the study phase you are participating in. The trial is designed to find the most appropriate dose and assess how well the medication works.
During the dose escalation phase (Part A), different dose levels will be tested to determine the safest and most effective dose.
During the dose optimization phase (Part B), the selected doses will be further evaluated for effectiveness and safety.
During the efficacy expansion phase (Part C), the chosen dose will be given to a larger group to confirm how well it works against cancer.
Treatment will continue as long as you are benefiting from it and not experiencing unacceptable side effects.
Step 3
Regular monitoring visits
Throughout the treatment period, you will attend regular clinic visits for monitoring and assessment.
At each visit, you will have a physical examination to check your overall health and any changes in your condition.
Blood tests will be performed regularly to monitor your PSA levels, organ function, and blood cell counts. These tests help detect any potential side effects early.
Vital signs such as blood pressure, heart rate, and temperature will be measured at each visit.
Periodic electrocardiograms (ECG) will be performed to monitor your heart function.
Imaging scans such as CT scans, MRI, or bone scans will be performed at scheduled intervals to assess how the cancer is responding to treatment. These scans will follow RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions, which are standardized methods to measure tumor response.
Any adverse events (side effects or unwanted reactions) will be recorded and assessed. You should report any new symptoms or health changes to the study team.
Your ECOG performance status will be evaluated regularly to monitor how the disease and treatment are affecting your daily activities.
In some cases, additional tumor biopsies may be taken during treatment to assess changes in the tumor and measure STEAP2 expression, a protein that may be related to treatment response.
Step 4
Treatment discontinuation
Treatment will be stopped if the cancer progresses, if you experience unacceptable side effects, or if you decide to withdraw from the study.
At the time of discontinuation, a final assessment will be performed, including physical examination, blood tests, and imaging scans.
The study team will discuss with you the reasons for stopping treatment and any further treatment options available.
Step 5
Follow-up period
After stopping treatment, you will enter a follow-up period during which your health will continue to be monitored.
Follow-up visits will include assessments of your overall health, survival status, and any subsequent cancer treatments you may receive.
Information about disease progression and overall survival will be collected during this period.
The duration and frequency of follow-up visits will be determined by the study protocol.
Step 6
Contraception requirements during and after treatment
If you are sexually active with a female partner who can become pregnant, you must use a condom (and spermicide if available) during the entire treatment period and for a specified time after the last dose of study medication.
It is strongly recommended that your female partner also use a highly effective method of birth control during this period.
You must not donate sperm while receiving treatment and for a specified period after the last dose.
You are encouraged to consider sperm preservation before starting treatment with AZD0516.

Who can join the trial?

16 criteria

You must be able to understand and sign the consent form, which means you agree to follow all the requirements of the study.
You must be at least 18 years old or the legal age to consent in your area.
You must be male, as assigned at birth, regardless of your current gender identity.
You must have a diagnosis of metastatic prostate cancer, which means prostate cancer that has spread to other parts of the body, confirmed by tissue examination. This diagnosis must show adenocarcinoma, which is the most common type of prostate cancer. Small areas of high grade neuroendocrine features, which are a specific type of cancer cell, are allowed.
You must have evidence that your cancer has spread beyond the prostate to other parts of the body, shown on scans such as CT, MRI, or bone scan. Cancer that has only spread to nearby lymph nodes in the pelvis or local areas does not qualify.
You must have undergone treatment to lower your testosterone levels, either through surgery to remove the testicles or through medication. Your testosterone level must be 50 nanograms per deciliter or lower, measured within 28 days before starting treatment.
If you are receiving medication to lower testosterone called GnRH modulator and have not had surgery to remove your testicles, this treatment must have started at least 2 weeks before you consent to the study and must continue during the study.
Your PSA level, which is a blood test that measures a protein made by the prostate, must be at least 1 nanogram per milliliter.
Your general health status must be good, rated as 0 or 1 on a scale called ECOG performance status, which means you are able to carry out normal activities or have only light restrictions.
Your doctor must believe you are likely to live at least 12 weeks.
Your organs and bone marrow must be working well enough, as shown by blood tests done within 21 days before starting the study treatment, without needing blood transfusions or medications to help produce blood cells.
You must have already tried standard treatments for your stage of cancer and your cancer has gotten worse, or you could not tolerate those treatments, or your doctor believes this study is the best next treatment option for you. If you cannot receive standard treatments for medical reasons, you may also qualify if this has been documented and you have been informed of all treatment options.
You must provide a sample of your tumor tissue, either from a previous biopsy stored as FFPE, which is a preserved tissue sample, or from a new biopsy.
If you are sexually active with a female partner who can become pregnant, including if your partner is already pregnant, you must use a condom and, if available, spermicide, which is a substance that prevents pregnancy, during the study and for a period of time after the last dose. It is strongly recommended that your female partner also uses a highly effective birth control method.
You must not donate sperm during the study and for a period of time after the last dose of study treatment.
Your doctor will advise you about preserving sperm before starting the study treatment.

Who cannot join the trial?

5 criteria

You cannot participate if you are female. This study is only for male patients.
You cannot participate if you are under 18 years old. This study is only for adult patients.
You cannot participate if you do not have metastatic prostate cancer, which means prostate cancer that has spread from the prostate gland to other parts of the body.
You cannot participate if your doctor determines that the study treatment would not be safe for you based on your overall health condition.
You cannot participate if you cannot tolerate the study procedures or follow the requirements of the clinical trial.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

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Investigated drugs

AZD0516 is an experimental anti-cancer medication being tested in this study. It is being evaluated both on its own and when combined with other cancer treatments to see how safe it is and how well it works in patients with metastatic prostate cancer, which is prostate cancer that has spread to other parts of the body.

The study also includes other anti-cancer agents, which are medications used to treat cancer. These will be given together with AZD0516 to see if the combination is safe and effective for treating metastatic prostate cancer.

What is already known about the treatment

AZD0516 – AZD0516 is an experimental anti-cancer medication currently being studied in clinical trials for the treatment of metastatic prostate cancer, which means prostate cancer that has spread to other parts of the body. This medication is being tested both as a single treatment and in combination with other cancer-fighting drugs to evaluate how safe it is, how well the body processes it, and how effective it might be in fighting cancer. The study is examining different doses to find the best amount to give patients while monitoring for side effects and measuring how well it works against tumors. As an investigational drug, AZD0516 is not yet approved for general medical use and is only available to patients participating in this research study.

Investigated diseases

Metastatic Prostate Cancer – This is a condition where prostate cancer has spread beyond the prostate gland to other parts of the body. The disease occurs when cancer cells break away from the original tumor in the prostate and travel through the bloodstream or lymphatic system to distant organs. Common sites where the cancer spreads include bones, lymph nodes, liver, and lungs. As the disease progresses, patients may experience bone pain, fatigue, weight loss, and difficulty urinating. The spreading cancer can affect the normal function of the organs it invades. This advanced stage of prostate cancer represents a progression from earlier, localized forms of the disease.