A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
This research study is investigating a new medicine called PF-08046876 for people who have advanced cancers, specifically those affecting the bladder, lung, head and neck, oesophagus (food pipe), or pancreas. This medicine falls into a group known as 'antibody drug conjugates' (ADCs), which are designed to specifically target and destroy cancer cells while trying to limit harm to healthy cells. The main goals of this study are to understand if PF-08046876 is safe to use and what effects it has on the cancer. Participants will receive the study medicine through a needle in a vein, often called an 'intravenous infusion'. The study will start by giving different doses to different groups of people to find the best way to give the medicine.
At a glance
What is this study about?
This study is designed to explore a new treatment called PF-08046876 for people living with advanced forms of cancer. Specifically, it's looking at cancers of the bladder, lung, head and neck, oesophagus (food pipe), and pancreas that are considered 'advanced' or 'metastatic' – meaning they have spread from where they started. The medicine, PF-08046876, is a type of treatment called an 'antibody drug conjugate' (often shortened to ADC). Imagine it like a guided missile: the 'antibody' part is like the guidance system that finds and sticks to cancer cells, and the 'drug conjugate' part is the medicine that then kills those cancer cells. This clever design aims to deliver the cancer-fighting drug directly to where it's needed while trying to protect healthy parts of the body.
The main reasons for doing this study are to find out if PF-08046876 is safe for people to take and to observe if it has any positive effects on their cancer. Because it's a new medicine, the study starts carefully. In the first part, different groups of people will receive varying amounts (doses) of the medicine to determine the safest and most effective dose. The medicine will be given to participants directly into a vein through a drip, similar to how many hospital treatments are administered.
By taking part in this study, you would be helping doctors and researchers learn more about new ways to fight cancer. Your participation could contribute to developing future treatments that might help many other people. It's important to remember that this is a research study, and while the aim is to find effective treatments, there are no guarantees about the outcome for individuals.
Key takeaways
- This study is testing a new cancer medicine called PF-08046876.
- It's for advanced cancers of the bladder, lung, head & neck, oesophagus, or pancreas.
- The medicine is an 'antibody drug conjugate' designed to target cancer cells.
- The main goals are to check for safety and how well the medicine works.
- Participants will receive the medicine through a drip into a vein.
- Strict eligibility rules apply, and close monitoring will be involved.
Who may be eligible?
To be able to join this study, there are certain requirements you would need to meet. You must be at least 18 years old. You should have advanced cancer of the bladder, lung, head and neck, oesophagus, or pancreas. The doctors need to be able to measure your cancer to see if the treatment is working. Your general health and ability to perform daily activities, often described as 'performance status', should be good.
If you're joining the first part of the study, your cancer should have progressed or come back after you've had standard treatments. For the second part of the study, you shouldn't have had more than two previous treatments targeting the whole body for your advanced cancer. Any side effects from your previous cancer treatments need to have mostly cleared up or be very mild. You also need to agree to provide a small sample of your tumour tissue, if it's safe to do so.
There are also some reasons why you wouldn't be able to join. For example, if you've already had a similar type of antibody drug conjugate medicine that contains a specific kind of drug (like sacituzumab govitecan or trastuzumab deruxtecan). Also, if you have severe eating problems, sickness, or bowel issues, or specific serious lung problems, you might not be suitable for this study. The study also has other specific health conditions that would prevent you from taking part.
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 advanced bladder, lung, head and neck, oesophageal, or pancreatic cancer?
- Has your cancer progressed or returned after previous treatments (if applicable for Part 1)?
- Have any side effects from your previous treatments mostly cleared up?
- Have you NOT received a similar type of 'antibody drug conjugate' medicine before?
- Are you generally well enough to manage daily activities?
What does participation involve?
If you decide to take part in this study, you will have regular visits to the hospital or clinic. During these visits, doctors and nurses will monitor your health closely, perform physical exams, take blood and urine samples, and do scans to see how the treatment is affecting your cancer. The medicine, PF-08046876, will be given to you through a drip into a vein. The exact number of visits and the full length of your participation will depend on which part of the study you are in and how you respond to the treatment, but studies like this usually involve ongoing visits over several months, followed by regular check-ups.
It's important to understand that research studies require careful monitoring, so you should expect to spend time at the clinic for your appointments and treatment. Nurses will be on hand to answer questions and help with any side effects. You will be told the complete schedule of visits and procedures before you agree to join the study.
Potential risks and benefits
Locations (28)
- City of Hope National Medical CenterVerified postcodeDuarte, United States· Recruiting
- City of Hope at Irvine LennarVerified postcodeIrvine, United States· Recruiting
- Ronald Reagan UCLA Medical CenterVerified postcodeLos Angeles, United States· Not yet recruiting
- UCLA Department of Medicine-Hematology/OncologyVerified postcodeLos Angeles, United States· Not yet recruiting
- Santa Monica UCLA Medical Center & Orthopaedic HospitalVerified postcodeSanta Monica, United States· Not yet recruiting
- UCLA Hematology/Oncology - Santa MonicaVerified postcodeSanta Monica, United States· Not yet recruiting
- Smilow Cancer Hospital - Yale New Haven HealthVerified postcodeNew Haven, United States· Recruiting
- Yale - New Haven Hospital - Yale Cancer CenterVerified postcodeNew Haven, United States· Recruiting
- Smilow Cancer Hospital Phase 1 UnitVerified postcodeNew Haven, United States· Recruiting
- Smilow Cancer Hospital - TrumbullVerified postcodeTrumbull, United States· Recruiting
- Brigham and Women's HospitalVerified postcodeBoston, United States· Recruiting
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
Common questions
What is an 'antibody drug conjugate'?
It's a clever type of medicine that combines a targeting part (the antibody) that finds cancer cells, with a powerful drug (the conjugate) that kills them. It's designed to be more precise.
How will I receive the medicine?
The medicine, PF-08046876, will be given to you through a drip into a vein, which is also known as an intravenous infusion.
Will I know if I'm getting the actual medicine or a dummy treatment?
In this specific study, all participants will receive the study medicine, PF-08046876. There isn't a dummy treatment (placebo) involved.
What kind of cancer does this study focus on?
This study is for people with advanced bladder, lung, head and neck, oesophageal (food pipe), or pancreatic cancer.
What does 'advanced cancer' mean?
Advanced cancer usually means the cancer has grown or spread from where it started in the body.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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