A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
This research study is looking into a new drug called PF-08046049/SGN-BB228. It's for people who have advanced melanoma or other solid cancers that are hard to treat or have spread to other parts of the body. The main goals are to find out a safe dose of the drug, understand its side effects, and see if it can help treat these cancers. The study has three parts. The first two parts will help doctors work out the right amount of the drug to give. The final part will then use this information to check both the safety and effectiveness of the new drug in treating these types of cancer.
At a glance
What is this study about?
This study is focused on people who have certain types of cancer, specifically advanced melanoma (a type of skin cancer) and other solid cancers such as lung, bowel, pancreatic cancer, or mesothelioma. These are cancers that have either come back, have not responded to usual treatments, or have spread to other parts of the body. The main aim is to test a new drug called PF-08046049/SGN-BB228.
The research has a few stages. Initially, doctors want to find the safest and most effective dose of this new drug. This helps them understand how much medicine to give to get the best results without too many serious side effects. Once they figure out the best dose, the study will then look more closely at how safe the drug is overall and how well it works to treat these cancers.
It's really important to find new treatments for cancers that are advanced or have not responded to current therapies. This study is an early-stage drug trial, meaning it's one of the first times this drug is being tested in people. The information gathered from this research will help doctors decide if PF-08046049/SGN-BB228 could be a helpful new option for patients in the future.
Key takeaways
- This study tests a new drug (PF-08046049/SGN-BB228) for advanced cancers.
- It's for specific advanced solid cancers, including melanoma, lung, bowel, and pancreatic cancer, and mesothelioma.
- The main goals are to find a safe dose and understand side effects.
- Participation involves regular visits, checks, and taking the study drug.
- It's a 'Phase 1' study, focusing on early safety and dosage information.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would need to have certain types of cancer that have advanced or are proving difficult to treat with standard methods. This includes melanoma that has spread or can't be removed with surgery, or other specific cancers like non-small cell lung cancer, bowel cancer, pancreatic cancer, or mesothelioma. Generally, your cancer must have come back, not responded to previous treatments, or you weren't able to tolerate those treatments.
For those with melanoma, you should have already received treatment with certain types of immunotherapy. If your melanoma has a specific genetic change (called a BRAF mutation), you should have already tried or not been able to take particular targeted therapies. They will also need a recent tissue sample from your cancer. You'll also need to be generally well enough to take part in the study, meaning you can mostly look after yourself.
There are also reasons why you might not be able to join. For example, if you've had another cancer in the last three years (unless it was a very minor one), or if you have active cancer that has spread to your brain. You also can't have taken part in a study involving drugs that target similar pathways to this new medicine previously. The medical team will check all these details carefully with 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.
- Do I have advanced melanoma, lung, bowel, pancreatic cancer, or mesothelioma?
- Has my cancer not responded to usual treatments, or have they been hard to tolerate?
- Have I had certain prior immunotherapies if I have melanoma?
- Am I generally well enough to manage daily activities?
- Do I have any cancer spread to the brain that is active or untreatable?
- Have I avoided other similar experimental drugs?
What does participation involve?
If you decide to take part in this study, you will be given the new drug, PF-08046049/SGN-BB228. The first two parts of the study are about finding the right dose, so the amount of drug you receive might be different from other participants. You will have regular visits to the hospital or clinic, where the study team will carry out health checks, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.
These assessments are crucial for the study doctors to understand the drug's safety and effectiveness. The number of visits and tests may vary depending on which part of the study you are in. You will be closely monitored throughout your time in the study and for a period afterwards. The total duration of your participation in the study would depend on how your body responds to the treatment and the stage of the study you are in.
Potential risks and benefits
Locations (36)
- UCLA Hematology/Oncology - Administrative OfficeVerified postcodeLos Angeles, United States
- The Angeles Clinic and Research Institue, A Cedars-Sinai AffiliateVerified postcodeLos Angeles, United States
- Cedars-Sinai Medical CenterVerified postcodeLos Angeles, United States
- Ronald Reagan UCLA Medical Center, Drug Information CenterVerified postcodeLos Angeles, United States
- UCLA Hematology/OncologyVerified postcodeLos Angeles, United States
- UCLA Hematology/ Oncology- PasadenaVerified postcodePasadena, United States
- UCSF Helen Diller Family Comprehensive Cancer CenterVerified postcodeSan Francisco, United States
- UCSF Medical Center, Investigational PharmacyVerified postcodeSan Francisco, United States
- UCLA Hematology/Oncology - Santa BarbaraVerified postcodeSanta Barbara, United States
- The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-up only)Verified postcodeSanta Monica, United States
- UCLA Hematology - Oncology Clinic - Westlake VillageVerified postcodeWestlake Village, United States
- Quest Diagnostics Incorporated - DenverVerified postcodeDenver, United States
Common questions
What is a 'solid tumor'?
A solid tumor is a lump of abnormal cells that doesn't contain cysts or liquid areas. Most cancers are solid tumors, like those found in the lung, breast, or bowel.
What does a 'Phase 1' study mean?
Phase 1 is the first stage where a new drug is tested in people. It mainly focuses on finding a safe dose and checking for side effects, rather than how well it treats the cancer.
What are 'side effects'?
Side effects are any unwanted or unexpected effects a medicine can have on your body, in addition to treating your illness. They can range from mild to serious.
Will this drug cure my cancer?
This is a Phase 1 study, focused on safety and finding the right dose. While some participants may see positive effects, it's too early to know if this drug will offer a cure. The study aims to understand its potential.
What is advanced melanoma?
Advanced melanoma means the skin cancer has grown deeply, spread to local lymph nodes, or to distant parts of the body.
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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