Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study of PF-08046031 in Adults With Advanced Melanoma and Other Solid Tumors

This study is looking at a new investigational medicine called PF-08046031. It's designed for adult patients who have advanced melanoma, which is a serious form of skin cancer, or other types of solid cancers, such as non-small cell lung cancer, head and neck cancer, or oesophageal (gullet) cancer. This is a very early-stage study, often called a Phase I study. This means it's one of the first times this new medicine is being given to people. The main goals are to find out if the medicine is safe, what doses can be given, and to understand how it behaves in the human body. Researchers also want to see if it might have any positive effects on these cancers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Pfizer Inc.

Enrolment target

Start

21 May 2025

Melanoma (or) malignant melanoma Non-small cell lung cancer Head and neck squamous cell carcinoma Esophageal cancer

What is this study about?

This study is for adults who have been diagnosed with certain types of advanced cancer. These include melanoma, which is a serious kind of skin cancer, as well as cancers affecting the lungs, head and neck, or the gullet (oesophagus). The study is testing a new medicine, called PF-08046031, which is still in its very early stages of development.

Because this is a very early study (it’s called a Phase I study), it means scientists are giving this new medicine to people for the first time. The main aim is to understand if it’s safe to use, what the best dose might be, and how it moves through and affects the body. They’re not just looking for safety, but also hoping to see if the medicine has any positive effects on these cancers.

Taking part in a study like this could help doctors learn more about managing these cancers in the future. Even if the medicine doesn't help every person in the study, the information gained is really important for developing new treatments that might help many others down the line.

Key takeaways

This study tests a new cancer medicine (PF-08046031) for the first time in people.
It's for adults with advanced melanoma, lung, head & neck, or oesophageal cancer.
The main goals are to check safety, find the right dose, and see how the medicine works.
You'll have regular hospital visits for monitoring and tests.
It could help doctors learn about future cancer treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, so older adults can also take part if they meet other health requirements.

Crucially, you must have one of the specific advanced cancers mentioned: melanoma (a type of skin cancer), non-small cell lung cancer, head and neck squamous cell carcinoma, or oesophageal cancer. Both men and women are welcome to participate.

There will be other detailed health checks to make sure your body can safely handle the new medicine and that the study results will be clear. A doctor will go through all the specific rules to see if this study is right 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 advanced melanoma, lung, head and neck, or oesophageal cancer?
Are you willing to attend regular hospital visits for check-ups and treatment?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the new medicine, PF-08046031. This is a very early-stage study, so it will involve regular visits to the hospital or clinic. During these visits, doctors and nurses will monitor you closely to check how you are reacting to the medicine and to see if there are any side effects. You can expect to have various checks, like blood tests, scans, and physical examinations. These assessments help the doctors understand how the medicine is working and its effects on your body. The total length of time you'd be involved in the study would depend on how you respond to the treatment and the study plan, which your doctor will explain in detail.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from this new medicine, but it could help doctors learn important information that helps future patients. There's also a chance the medicine could help your cancer. However, as this is a new medicine, there might be side effects or risks that are not fully known yet. Researchers will monitor you very closely for any issues. You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

—
Unverified
Germany
—
Unverified
Sweden
—
Unverified
France
—
Unverified
Netherlands
—
Unverified
Spain

Common questions

What does 'advanced' cancer mean?

Advanced cancer means the cancer has spread from where it started or cannot be cured with current standard treatments.

What is a 'Phase I' study?

A Phase I study is the first time a new medicine is tested in people. Its main goal is to check safety and find the right dose, rather than curing the disease.

Will I know if I'm getting the actual medicine or a dummy pill?

In this early phase study, it's very likely that all participants will receive the active study medicine, PF-08046031. There shouldn't be a dummy pill (placebo) in this type of trial.

What kind of tests will I have if I join?

You can expect regular health checks, including blood tests, physical examinations, and possibly scans (like X-rays or CT scans) to monitor your health and the cancer.

Can I continue my other cancer treatments while in the study?

This will depend on the specific rules of the study. Usually, you would not be able to continue other active cancer treatments that might interfere with the new medicine. Your doctor will explain this thoroughly.