RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer

This research study is looking at a new investigational drug, GDC-1261, for men who have advanced or metastatic prostate cancer. This means the cancer has spread from where it started. The main goals of the study are to check if the drug is safe to use and to understand how it behaves in the body, including how much of it gets into your system and how long it stays there. We also want to see if there are any early signs that GDC-1261 might help to treat the cancer. An important part of the study is to find the most suitable dose of the drug for any future, larger studies.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Genentech, Inc.

Enrolment target

260

Start

29 Apr 2026

Estimated completion

30 Dec 2027

Advanced Prostate Cancer Metastatic Prostate Cancer

What is this study about?

This study is investigating a new medication, GDC-1261, for men whose prostate cancer is advanced, meaning it has grown significantly, or has spread to other parts of the body (this is called metastatic prostate cancer). When new medicines are developed, they go through different stages of testing. This study is in the early to middle stages (Phase 1/2), which means it's one of the first times this drug is being given to people with this specific type of cancer.

The main aim is to carefully monitor the safety of GDC-1261. Researchers will be looking for any side effects and how well people tolerate the treatment. They also want to understand how the drug is processed by the body – for example, how much of it enters the bloodstream, how long it stays there, and how the body gets rid of it. This helps them figure out the best way to give the drug. We will also be looking for any early signs that the drug might be effective in slowing down or shrinking the cancer.

Ultimately, the information gathered from this study will help determine the best dose and schedule for GDC-1261 if it moves into larger, later-stage clinical trials. This is a crucial step in potentially developing a new treatment option for prostate cancer.

Key takeaways

This study is testing a new drug (GDC-1261) for advanced or metastatic prostate cancer.
It's primarily focused on safety and understanding how the drug works in the body.
The goal is to find the right dose for future, larger studies.
You'll have regular hospital visits, blood tests, and scans.
Participation is voluntary, and you can withdraw at any time.
The drug is investigational, so its full benefits and risks are not yet known.

Who may be eligible?

To join this study, you would need to be a man, aged 18 or older, who has been diagnosed with advanced or metastatic prostate cancer. This means your cancer has spread to other parts of your body, and it must have progressed despite your current or most recent treatment. You also need to be fit enough for daily activities and have a life expectancy of at least three months. Your body's organs, like your liver and kidneys, need to be working well, and you must currently be receiving or have had hormone therapy (like ADT) or have had surgery to remove your testicles.

There are also reasons why you might not be able to join. For example, if you've recently had other cancer treatments, like chemotherapy, within the last two weeks, or if you have certain health issues like untreated cancer that has spread to your brain, unstable bone problems, or uncontrolled pain. You also couldn't join if you've had other types of cancer in the last five years, or if you have an active infection that needs strong medication.

Deciding if you're suitable also depends on the study doctor's judgment about your overall health, to make sure it's safe for you to take part and that the study results will be clear.

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 man, aged 18 or older?
Do you have prostate cancer that has spread?
Has your cancer gotten worse despite recent treatment?
Are you currently receiving or have you had hormone therapy for prostate cancer?
Are you generally fit for daily activities?
Have you *not* had other cancer treatments within the last two weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the investigational drug, GDC-1261. The exact schedule of how often you'll take the drug and for how long will be explained by the study team. You will have regular visits to the hospital or clinic, which will likely include physical examinations, blood tests, and scans (like CT or bone scans) to monitor your health, check for side effects, and see how the cancer is responding. These tests are important for understanding how the drug is working and if it's safe.

The study team will provide you with all the necessary medication and instructions. You'll need to keep a record of any side effects you experience. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout. Even after you stop taking the study drug, you will likely have follow-up visits or calls to track your long-term health and any side effects.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits, such as receiving a new investigational treatment that isn't yet widely available. There's a chance the treatment could help manage your cancer, but this is not guaranteed, as the drug is still being tested. It also contributes to scientific knowledge that may help others in the future. However, there are potential risks, as GDC-1261 is a new drug and may cause side effects that are currently unknown or not fully understood. You will be closely monitored for any health changes. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Honor Health Research Institute
Verified postcode
Scottsdale, United States· Recruiting
Sarah Cannon Research Institute
Verified postcode
Nashville, United States· Recruiting
St Vincent's Hospital Sydney
Verified postcode
Darlinghurst, Australia· Recruiting
Austin Hospital
Verified postcode
Heidelberg, Australia· Recruiting
The Royal Marsden in Sutton, Surrey - Downs Rd
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What does 'investigational drug' mean?

It means the drug, GDC-1261, is still being tested in clinical trials and has not yet been approved for general use by healthcare authorities.

Will I still receive my usual prostate cancer treatment?

You must be continuing your hormone therapy (like ADT) or have had a specific surgery, but other current cancer treatments might need to be stopped for a short time before joining the study.

What kind of tests will I have during the study?

You can expect regular physical exams, blood tests, and scans to monitor your health and how your cancer is responding to the treatment.

Can I leave the study at any time?

Yes, you have the right to leave the study at any time, for any reason, and this will not affect your ongoing medical care.

What is 'metastatic prostate cancer'?

This means your prostate cancer has spread from the prostate gland to other parts of your body, such as your bones or lymph nodes.

How to find out more

Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.

global-roche-genentech-trials@gene.com 888-662-6728 Official trial record

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