C6461013 - An Interventional Open-label Phase 1b/2 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 as Monotherapy and Combination Therapy in Adult Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
This research study is looking at a new treatment called PF-08634404 for adults who have a type of advanced liver cancer that surgeons cannot remove. The study will test this new medicine by itself and also in combination with another approved cancer medicine called YERVOY. The main goals are to understand if PF-08634404 is safe to use and what side effects it might cause. Researchers also want to see how the new medicine works in the body and if it can help to slow down or shrink the cancer. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in a larger group of people with this specific cancer.
At a glance
What is this study about?
This study is looking into an investigational drug called PF-08634404 for adults diagnosed with hepatocellular carcinoma, a common type of liver cancer. Specifically, it's for people whose cancer is advanced and cannot be treated with surgery. The research will explore PF-08634404 in two ways: first, on its own as a single treatment, and second, combined with an already approved cancer medicine called YERVOY. The hope is to find a new and effective way to fight this challenging cancer.
The study has two main parts. The first part, called Phase 1b, focuses on safety. In this phase, a small group of participants will receive different doses of the new medicine. Doctors will carefully watch for any side effects and how severe they are to find the safest dose. They will also look at how the body handles the medicine.
Once a safe dose is identified, the study moves into Phase 2. In this larger part, more participants will receive the treatment. The main goal here is to see how well the medicine works at shrinking the cancer or stopping it from growing, while still keeping a close eye on safety and side effects. This careful, step-by-step approach helps ensure patient safety while developing new treatments.
Key takeaways
- This study is for adults with advanced liver cancer that cannot be surgically removed.
- It tests a new medicine (PF-08634404), sometimes with another drug (YERVOY).
- The main goals are to check for safety and how well the treatment fights cancer.
- Participation involves regular clinic visits, blood tests, and scans.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, participants must be adults, aged 18 or older, regardless of their gender. They need to have a specific type of advanced liver cancer called hepatocellular carcinoma that cannot be removed by surgery.
Beyond age and cancer type, there will be other important medical criteria to make sure the study is safe for everyone involved and that the results are clear. For example, doctors will check your overall health, how well your liver and kidneys are working, and if you have any other serious medical conditions. You cannot be pregnant or breastfeeding, for instance.
It's very important to discuss your complete medical history with the study team. They will review all your health information and current treatments to confirm if this study is the right and safest choice for you. Only the study doctor can fully determine if you meet all the requirements.
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 liver cancer (hepatocellular carcinoma)?
- Has your doctor told you that your liver cancer cannot be removed with surgery?
- Are you able to travel to regular clinic appointments?
- Are you willing to follow all study procedures, including taking the study medicine and undergoing tests?
What does participation involve?
If you decide to join this study, you will receive the investigational medicine (PF-08634404) and possibly YERVOY, through an infusion (a drip into your vein). The dose and combination will depend on which part of the study you are in. You’ll need to attend regular clinic visits where doctors will monitor your health very closely. These visits will involve blood tests, physical exams, and imaging scans (like CT or MRI) to check how the medicine is affecting your body and your cancer. You might also be asked to provide urine samples or other body fluid samples. The frequency of visits will be more often at the beginning of the study and may become less frequent over time. While the total duration of your participation can vary, you will continue treatment as long as it is safe and helpful, and you'll have follow-up visits even after treatment stops.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What type of cancer is this study for?
This study is for adults with a type of advanced liver cancer called hepatocellular carcinoma that cannot be removed by surgery.
What is PF-08634404?
PF-08634404 is a new, investigational medicine being tested in this study to see if it can help treat liver cancer.
What does 'unresectable' mean?
'Unresectable' means that the cancer cannot be completely removed through an operation or surgery.
Will I get PF-08634404 alone or with another drug?
The study is testing PF-08634404 both by itself and in combination with another approved medicine called YERVOY.
What are the main things the doctors are looking for in this study?
Doctors are mainly looking at the safety of the new medicine (side effects) and whether it can help shrink the cancer or stop it from growing.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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