RecruitingPHASE1INTERVENTIONAL

A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

This study is looking into a new medication called RO7656594 for men who have advanced prostate cancer that has spread to other parts of the body. The main goals are to find out whether the drug is safe to use and how well people tolerate it. Researchers will also be checking how the drug behaves in the body, such as how long it stays in the system and if it shows any early signs of helping to control the cancer. The information gathered from this study will be used to work out the best dose and way to give RO7656594 for future studies. This is a very early-stage study, meaning it's one of the first times this drug is being tested in humans.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Genentech, Inc.

Enrolment target

210

Start

02 May 2023

Estimated completion

30 Jun 2027

Advanced Prostate Cancer Metastatic Prostate Cancer

What is this study about?

This research study is about a new drug, RO7656594, which is being investigated as a potential treatment for men with prostate cancer. Specifically, it's for those whose cancer is considered advanced or has spread to other parts of the body (metastatic prostate cancer).

The main purpose of this study is to understand more about RO7656594. Researchers want to see if it's safe and well-tolerated by patients, and how it moves through and is processed by the body. They will also be looking for any early signs that the drug might be effective in tackling the cancer. By doing this, the team hopes to identify the best dose and treatment plan for RO7656594 to be used in future, larger studies.

This is a 'Phase 1' study, which means it's one of the first times the drug is being tested in people. This stage of research is crucial for gathering initial information on safety and dosage before potentially moving on to bigger trials that will more definitively assess how well the drug works.

Key takeaways

This is an early-stage study (Phase 1) for a new drug, RO7656594.
It's for men with advanced or metastatic prostate cancer.
The primary focus is to check safety, tolerability, and find the right dose.
Researchers will also look for any early signs of the drug working.
Participants must have had certain prior prostate cancer treatments.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to be a male aged 18 or over with prostate cancer that has advanced or spread. Your cancer cells should be a specific type (adenocarcinoma) and not show certain features. You would also have already had treatment with a specific type of hormone therapy (called a second-generation AR-targeted therapy) and either had chemotherapy with a taxane drug, or been told it's not suitable for you, or decided not to have it.

If you have a known genetic change in the BRCA1 or BRCA2 genes, you would also need to have had a PARP inhibitor drug, or been told it's not suitable or available for you. Your general health and ability to carry out everyday activities, as assessed by doctors, would also need to be good.

There are also some reasons why you might not be able to join. For example, if you've recently had other anti-cancer treatments or treatments as part of another research study. You also wouldn't be able to join if you've previously received a similar type of drug to the one being tested in this study. If your cancer has spread to your brain or spinal cord and is not currently being treated, you would also not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a male aged 18 or older with advanced or metastatic prostate cancer?
Have you already received a 'second-generation AR-targeted therapy' (like abiraterone or enzalutamide)?
Have you had chemotherapy with a 'taxane' drug, or is it not suitable for you?
Have you not had any other research treatments in the last 28 days?
Do you not have untreated cancer spread to your brain or spinal cord?
Are you generally well and able to perform daily activities with ease?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the new drug, RO7656594, likely in cycles over a period of time. You'll have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health, how the drug is affecting you, and how your body is handling it. This will help doctors understand the drug's safety and any initial effects on your cancer. These visits will be more frequent at the beginning of the study. The total duration of your participation will depend on how you respond to the treatment and the study plan, but there will be ongoing follow-up to monitor your progress and health over time.

Potential risks and benefits

Participating in a clinical trial like this may offer the potential benefit of accessing a new treatment before it's widely available. However, because this is an early-stage study, we don't know much about the drug's effectiveness or all its potential side effects. There could be risks of side effects, some of which might be serious. Your doctors and the study team will monitor you very closely. It's very important to remember that participating is entirely your choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

HonorHealth
Verified postcode
Scottsdale, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Sarah Cannon Research Institute @ Florida Cancer
Verified postcode
Orlando, United States· Recruiting
University of Illinois Hospital & Health Sciences System
Verified postcode
Chicago, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
St Vincent's Hospital Sydney
Verified postcode
Darlinghurst, Australia· Recruiting
Macquarie University Hospital
Unverified
New South Wales, Australia· Recruiting
Monash Health Monash Medical Centre
Verified postcode
Clayton, Australia· Recruiting
Austin Hospital
Verified postcode
Heidelberg, Australia· Recruiting
British Columbia Cancer Agency
Verified postcode
Vancouver, Canada· Recruiting
Princess Margaret Hospital
Verified postcode
Toronto, Canada· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting

Common questions

What is 'Phase 1' of a clinical trial?

Phase 1 is the first stage where a new drug is tested in people. The main goals are to check its safety, find the best dose, and understand how the body handles it.

What is 'advanced or metastatic prostate cancer'?

This means your prostate cancer has either grown outside the prostate gland into nearby tissues, or it has spread to other parts of your body, such as bones or lymph nodes.

What is RO7656594?

RO7656594 is the name of the new experimental drug being tested in this study. It's investigational, meaning it's not yet approved for general use.

Will this drug cure my cancer?

It's too early to say if this drug will cure cancer. The aim of this early study is to understand its safety and if it shows any initial signs of helping against the cancer. We cannot make firm claims about its effectiveness at this stage.

What does 'pharmacokinetics' mean?

Pharmacokinetics refers to what the body does to the drug – how it absorbs, distributes, breaks down, and gets rid of the drug. Understanding this helps find the right dose.

How to find out more

GO44537 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.