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

A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors

This is a very early study looking at a new medicine, PF-08046049/SGN-BB228, for people with advanced melanoma and other solid cancers such as bowel, lung, pancreatic cancer, and mesothelioma. It's called a Phase 1 study, which means it's the first time this drug is being given to people. The main goals are to check if the drug is safe, what side effects it might have, and how it behaves in the body. Researchers also want to find the best dose to use in future studies. This research could help doctors understand if this new drug has the potential to become a treatment option for these types of cancers.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Seagen Inc.
Enrolment target
45
Start
08 Aug 2023

What is this study about?

This study is investigating a new potential cancer medicine known by its research name, PF-08046049/SGN-BB228. It's being tested in people who have advanced melanoma, which is a type of skin cancer, and other solid tumour cancers, including those affecting the pancreas, bowel (colorectal cancer), lungs (non-small cell lung cancer), and a rare cancer called mesothelioma.

This is a 'Phase 1' study, which is the very first step in testing a new drug in humans. The main purpose of this phase is not to cure cancer, but to carefully check the drug's safety, understand how the body handles it, and identify any side effects. Researchers will also be looking for the highest dose that can be given safely to patients. Think of it like taking the first few careful steps with a new medicine; it's about making sure it's safe to use before exploring how effective it might be.

By taking part, individuals contribute vital information that helps researchers decide if this new drug is promising enough to move on to larger studies. This kind of early research is crucial for developing new cancer treatments in the future, potentially offering new options where existing treatments might no longer be working.

Key takeaways

  • This is an early-stage study for a new cancer drug.
  • It's testing safety and how the drug works, not primarily aiming for a cure.
  • It's for specific advanced cancers like melanoma, bowel, lung, and pancreatic cancer.
  • Participation involves regular hospital visits for tests and medication.
  • Potential for benefit and known risks of side effects will be discussed.
  • You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you generally need to be at least 18 years old. The study is open to both men and women.

Because this is a study for people with advanced cancer, you would need to have been diagnosed with one of the specific cancers being investigated, such as advanced melanoma, pancreatic cancer, bowel cancer, lung cancer (non-small cell type), or mesothelioma. Your doctors would need to confirm that your cancer fits the study's requirements.

There will also be other medical checks and criteria that your doctor will review to make sure this study is safe and appropriate for you. These might include your general health, how well your organs are working, and whether you've had certain treatments before. It's important to discuss all your medical history with the study team.

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.

  1. Are you 18 years old or older?
  2. Do you have advanced melanoma, pancreatic, bowel, lung (non-small cell), or mesothelioma cancer?
  3. Are you generally well enough to take part in a study?
  4. Are you able to attend regular hospital visits?
  5. Are you willing to follow the study's rules and schedules?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have various assessments. These typically include physical examinations, blood tests and possibly urine tests, and scans (like CT scans) to monitor your health and how the treatment might be affecting your cancer. You would also be given the study medication, PF-08046049/SGN-BB228, which might be given as an infusion or in another form, depending on how the drug is designed. The study team will carefully explain the schedule for your medication.

Beyond these regular visits, there would also be follow-up appointments after you stop taking the study drug, to continue monitoring your health and any long-term effects. The total duration of your participation would vary depending on how you respond to the treatment and the specific study plan, but Phase 1 studies often involve a period of active treatment followed by monitoring.

Potential risks and benefits

As with any new medicine, there are potential benefits and potential risks to consider. The main potential benefit is that this new drug might help to slow down or even shrink your cancer, especially if other treatments haven't worked well for you. However, since this is a very early study, we don't know yet how effective it will be. Potential risks include experiencing side effects, some of which could be serious, as the research team learns more about the drug. You will be closely monitored for any reactions, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

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

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the very first time a new drug is given to people. It mainly checks if the drug is safe, what dose to use, and if it has any side effects.

Will this drug cure my cancer?

The goal of this early study is not to cure cancer, but to understand if the drug is safe and how it works. It's a first step in developing new treatments.

What cancers does this study include?

It includes advanced melanoma, pancreatic, bowel, and lung cancer (non-small cell type), and mesothelioma.

Will I have to pay to join the study?

No, you will not have to pay for the study drug or any study-related medical care.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your decision will not affect your usual medical care.

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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