RecruitingPHASE1INTERVENTIONAL

A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer

This research study is about a new medicine called PF-08052667 for bladder cancer that affects only the inner lining (non-muscle invasive). It aims to understand how this new medicine works, either by itself or when used with other treatments like BCG and sasanlimab. The study focuses on adults whose bladder cancer is likely to return or grow, or has already returned after standard treatments. It's also for those who can't have standard treatments. The study has three parts, gradually testing different doses and combinations of these medicines. All participants receive PF-08052667, which is given directly into the bladder. Some will also receive other medicines by injection under the skin. The treatment will last a maximum of about two years, with longer-term follow-up.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Pfizer

Enrolment target

294

Start

06 Nov 2025

Estimated completion

28 Jan 2033

Non-muscle Invasive Bladder Cancer

What is this study about?

This study is designed to explore a new treatment, PF-08052667, for a specific type of bladder cancer. This cancer is found in the lining of the bladder but hasn't grown into the deeper muscle layers. This is often called 'non-muscle invasive bladder cancer'. While it hasn't spread deep, it can still come back or get worse, even after standard treatments like BCG (Bacillus Calmette-Guérin).

The main goal of the study is to see how well PF-08052667 works. Researchers want to understand if it's effective on its own or when combined with BCG and/or another medicine called sasanlimab. They're particularly interested in people whose cancer has returned after standard treatments, or for whom standard treatments aren't suitable or available. By testing different doses and combinations, they hope to find the safest and most effective ways to use these medicines.

The study has three parts. First, they'll carefully increase the dose of PF-08052667 by itself. Then, they'll test PF-08052667 with BCG and/or sasanlimab. Finally, they'll use the best doses found in the first two parts to further understand how these treatments work. This careful approach helps ensure patient safety while finding the most promising treatment strategies.

Key takeaways

This study is for a new medicine for non-muscle invasive bladder cancer.
It tests the medicine alone or with existing treatments like BCG.
Participants must have high-risk bladder cancer that has come back or not responded to prior treatments.
The new medicine is given directly into the bladder.
Treatment can last up to two years, with longer follow-up.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a specific type of bladder cancer called 'high-risk, non-muscle invasive bladder cancer'. This means the cancer is in the bladder lining and has a higher chance of coming back or getting worse, or it might be a type called carcinoma in situ (CIS). If your cancer has returned or hasn't improved after at least five doses of BCG treatment, you might be suitable. Also, if your doctor believes a major bladder removal surgery (radical cystectomy) isn't right for you, you could be considered.

There are also some reasons why you might not be able to join. You can't be receiving other cancer treatments for your bladder cancer at the same time, and you shouldn't have had radiation therapy to your bladder in the past. If you have serious kidney or liver problems, or blood issues, or an active, uncontrolled infection, you would also not be able to participate. Doctors will check all these details carefully to make sure the study is safe for you.

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 18 years old or older?
Do you have high-risk non-muscle invasive bladder cancer that has returned or not improved after previous treatments (like BCG)?
Have you been told by your doctor that a major bladder removal surgery is not suitable for you?
Are you not currently receiving other cancer treatments for your bladder cancer (apart from the study medicines)?
Do you not have serious uncontrolled infections or significant kidney, liver, or blood problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new medicine PF-08052667. This medicine is given directly into your bladder using a thin tube (intravesical infusion). Depending on which part of the study you are in, you might also receive BCG and/or sasanlimab. Sasanlimab is given as an injection just under your skin (like an insulin shot). You will have regular visits for check-ups and assessments to see how you are responding to the treatment and to monitor for any side effects.

Treatment with the study medicines can continue for up to about two years, or until you or your doctor decide it's best for you to stop. Even after you stop treatment, the study team will continue to follow up on your health for a longer period. This helps researchers understand the long-term effects of the treatment. The total length of your involvement in the study will vary, as long-term follow-up could continue until the study ends or you are no longer able to be contacted.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are also potential risks, including side effects from the medicines, which can be mild or serious. The new medicine might not work for you, or it could even make your condition worse. You will be told about all known risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

The Kirklin Clinic of UAB Hospital
Verified postcode
Birmingham, United States· Recruiting
UAB Infusion Therapy Extended Care Clinic (ECC)
Verified postcode
Birmingham, United States· Recruiting
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
Verified postcode
Birmingham, United States· Recruiting
University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Moffitt Cancer Center at SouthShore
Verified postcode
Ruskin, United States· Recruiting
Moffitt Cancer Center - International Plaza
Verified postcode
Tampa, United States· Recruiting
Moffitt Cancer Center - McKinley Campus
Verified postcode
Tampa, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Moffitt McKinley Hospital
Verified postcode
Tampa, United States· Recruiting
Moffitt Cancer Center at Wesley Chapel
Verified postcode
Wesley Chapel, United States· Recruiting
Emory University Hospital Midtown
Verified postcode
Atlanta, United States· Recruiting
Emory University Hospital
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is 'non-muscle invasive bladder cancer'?

This is a type of bladder cancer that has only affected the inner lining of your bladder and has not spread into the deeper muscle layer.

What is BCG?

BCG is a standard treatment for non-muscle invasive bladder cancer, which uses a weakened form of bacteria to stimulate your immune system to fight the cancer.

How is PF-08052667 given?

It is given directly into your bladder through a thin tube, a method called an intravesical infusion.

How long will I be in the study?

Treatment can last up to about two years, but you will have follow-up checks for a longer time, depending on the study's plan.

Can I stop the study at any time?

Yes, you are free to leave the study at any point without it affecting your other medical care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

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