C6461006 - An Interventional Phase 1b/2, Open-Label Study to Investigate the Safety, Antitumor Activity, and Pharmacokinetics of PF-08634404 Monotherapy or in Combination With Enfortumab Vedotin in Adult Participants With Locally Advanced or Metastatic Urothelial Cancer.
This research study is looking into a new treatment called PF-08634404, either by itself or combined with a drug already in use called Enfortumab Vedotin (Padcev). It's for adult patients who have bladder cancer that has spread or is advanced. The main goals are to find out if the new treatment is safe for people to take, how effectively it shrinks or stops the cancer from growing, and how the medicine moves through and is processed by the body. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in humans, to gather important information for future research.
At a glance
What is this study about?
This study is designed to explore a new potential treatment for a type of cancer that affects the bladder and surrounding areas, known as urothelial cancer. Specifically, it's for patients whose cancer has either advanced locally (meaning it has grown into nearby tissues) or has spread to other parts of the body (metastatic).
The new drug being tested is called PF-08634404. Researchers want to see if it can be a safe and effective treatment when given alone, or when combined with another drug that is already approved for use, called Enfortumab Vedotin (which you might know by its brand name, Padcev). The study is divided into two main parts called Phase 1b and Phase 2. Phase 1b focuses on safety and finding the right dose, while Phase 2 looks more at how well the treatment works against the cancer.
Throughout the study, doctors will carefully monitor participants for any side effects and will also measure how the cancer responds to the treatment. This includes checking if tumors shrink or stop growing. They will also look at how the drugs are absorbed, distributed, metabolized, and excreted by the body. The aim is to gather crucial information to help understand if this new treatment could be a valuable option for patients in the future.
Key takeaways
- This study is testing a new drug for advanced bladder cancer.
- It aims to find out if the treatment is safe and effective.
- The new drug may be given alone or with an existing medicine.
- Adults 18 and over with advanced bladder cancer might be eligible.
- Participation involves clinic visits, infusions, and regular health checks.
Who may be eligible?
To be considered for this study, you must be an adult with bladder cancer (urothelial cancer) that has spread or is advanced. Both men and women are welcome to take part. There are no upper age limits, so anyone 18 years old or older can be considered.
Like all clinical trials, there will be specific health requirements and other criteria that you would need to meet to ensure the study is safe and appropriate for you. Your doctor will discuss these in detail. For example, they will check your overall health, how your kidneys and liver are working, and if you have other medical conditions that might affect how the drugs work or cause complications.
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 a diagnosis of advanced or spread bladder cancer (urothelial cancer)?
- Are you able to travel to clinic visits regularly?
- Are you willing to follow the study's treatment and testing schedule?
What does participation involve?
If you decide to take part in this study, you will receive either the new medicine PF-08634404 on its own, or a combination of PF-08634404 and Padcev. These medications are given through an infusion, which means they are delivered directly into your bloodstream, usually through a drip in your arm. You will have regular visits to the clinic for these treatments and for check-ups.
During your visits, the study team will carry out various assessments. These will include blood tests to see how your body is reacting to the treatment and to check for any side effects, and scans (like CT or MRI scans) to see how your cancer is responding. They will also ask you questions about how you are feeling. The exact number of visits and the full duration of your participation will depend on which part of the study you are in and how your body responds to the treatment, but the team will explain this clearly to you before you join. There will also be a follow-up period after your treatment finishes to continue monitoring your health.
Potential risks and benefits
Locations (2)
- —UnverifiedNetherlands
- —UnverifiedSpain
Common questions
What kind of cancer is this study for?
This study is for adults with bladder cancer (called urothelial cancer) that has spread or is advanced.
What are the treatments being tested?
The study is testing a new medicine called PF-08634404, either by itself or with an existing drug called Enfortumab Vedotin (Padcev).
What does 'Phase 1b/2' mean?
This means it's an early-stage study. Phase 1b mainly checks if the new treatment is safe and helps find the right dose, while Phase 2 then looks at how well it works against the cancer.
Who can join the study?
Adults aged 18 and over, both men and women, with this type of advanced bladder cancer may be eligible. Specific health checks will be done by the study team.
What will my doctor be looking for in the study?
Doctors will be looking at how safe the treatment is, if your cancer shrinks or stops growing, and how your body handles the medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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