Phase 1 Study of PF-08046033 in Advanced Solid Tumors
This is a Phase 1 clinical trial looking at a brand-new experimental cancer medicine named PF-08046033. Because this is the first time the medicine is being tested in people, the main goal is not to cure cancer, but to check its safety. The study is designed for adults aged 18 and older who have an advanced solid tumour (such as lung, breast, or bowel cancer) that has grown or spread, and for which standard treatments are no longer working or suitable. Researchers want to discover the safest dose of PF-08046033, learn what side effects it might cause, and see how the drug moves through the body. A small number of patients will receive the treatment under very close medical supervision in hospital. Taking part is completely voluntary.
At a glance
What is this study about?
A solid tumour is an abnormal mass of cells that forms in an organ or tissue, such as the lungs, breasts, colon, or kidneys. When a tumour is described as 'advanced', it usually means it has grown into nearby tissues or spread to other parts of the body. In many cases, standard treatments like chemotherapy or surgery may have stopped working or may not be an option. Researchers are constantly looking for new ways to treat these cancers.
This trial is testing a new experimental drug called PF-08046033. This medicine has been designed in a laboratory and tested in scientific models, but this study marks the very first time it is being given to humans. Trials like this are known as 'first-in-human' or Phase 1 studies. They are a crucial first step in finding out whether a potential new medicine can be used safely in patients.
The primary focus of this study is safety. Doctors will start by giving very low doses to a small group of people. If that dose is safe, the next group will receive a slightly higher dose. This gradual process helps researchers pinpoint the ideal dose to test in larger future studies. While it is hoped the drug might help control tumour growth, the main purpose right now is to understand its safety profile and how the human body processes it.
Key takeaways
- Tests a brand-new experimental drug (PF-08046033) in humans for the first time.
- Open to adults aged 18 and older with advanced solid tumours.
- Mainly focuses on finding safe dosage levels and watching for side effects.
- Requires frequent hospital visits, blood tests, and scans for safety monitoring.
- Participation is entirely voluntary, and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with an advanced solid tumour. It is generally aimed at people whose cancer has spread or cannot be removed with surgery, and who have already tried standard NHS treatments without success, or have no suitable standard options left.
Because this is a Phase 1 study, participants must be well enough to cope with the treatment and frequent hospital checks. The study team will assess your day-to-day energy levels, blood test results, and how well your major organs (such as your liver, kidneys, and heart) are functioning.
You may not be eligible if you have certain other serious health conditions, active infections, or if you are pregnant or breastfeeding. The trial doctors will review your full medical history to make sure taking part is as safe as possible 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.
- I am aged 18 or older.
- I have been diagnosed with an advanced solid tumour (cancer).
- Standard cancer treatments are no longer working, or I have run out of approved options.
- I am well enough to travel to hospital visits and carry out daily activities.
- I am willing to undergo extra blood tests, scans, and frequent monitoring.
What does participation involve?
Taking part in this study involves regular visits to a specialist hospital. At the start, you will have screening tests, such as blood tests, heart traces (ECGs), and imaging scans (like CT or MRI scans), to confirm that the trial is safe for you. If you join, you will be given the study drug PF-08046033, which may be taken as a tablet or given via a drip into a vein. You will need to stay at the clinic for several hours on treatment days so the team can monitor you closely for any reactions. Doctors will take regular blood samples to measure the drug levels in your body. Scans will be repeated every few weeks or months to monitor your cancer. You can remain on the study as long as the treatment is safe for you and your cancer does not worsen, but you are free to leave at any time.
Potential risks and benefits
Locations (3)
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What does a Phase 1 trial mean?
A Phase 1 trial is the earliest stage of testing a medicine in humans. Its main purpose is to test safety, find the best dose, and see what side effects occur, rather than proving how well it cures a disease.
Will I receive a dummy drug (placebo)?
In early-phase trials like this for advanced cancer, placebos are rarely used. All participants usually receive an active dose of the experimental medicine.
Will taking part cure my cancer?
It is unlikely. Because this trial is testing safety and dosage for the very first time, doctors do not yet know how well the drug works against cancer in humans.
Can I leave the study if I change my mind?
Yes. You can leave the study at any time and for any reason. Your standard medical care will not be affected in any way.
Does taking part cost anything?
No, the trial treatment and extra tests are free. Many trials also help cover travel expenses, such as train fares or parking.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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