A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
This study, called EMBOLD, is looking into a new drug named Ris-Rez (also known as GSK5764227) for people with advanced solid cancers. The main goals are to understand if Ris-Rez is safe, how well people tolerate it, and if it shows signs of helping to treat the cancer. Researchers will also check how the body handles the medicine over time when given by itself and when combined with other common cancer drugs like cisplatin, carboplatin, or atezolizumab. This is an early-stage study (Phase 1) focused on finding the right dose and understanding the drug's basic effects.
At a glance
What is this study about?
This study, called EMBOLD, is an early-stage clinical trial (Phase 1) looking at a new medicine called Risvutatug rezetecan, or Ris-Rez for short. It's designed for people who have advanced solid cancers, which means their cancer has grown or spread. The main purpose is to carefully check if this new drug is safe to use and how well people can tolerate it. Understanding the side effects and how the body handles the drug are big priorities at this stage.
The researchers are also interested to see if Ris-Rez shows any signs of slowing down or shrinking the cancer. They will be testing the drug in two ways: first, by giving it alone, and then by trying it in combination with other established cancer treatments like cisplatin, carboplatin, atezolizumab, and others. This helps them learn if Ris-Rez works better when combined with existing therapies, which is a common approach in cancer treatment.
This type of study is crucial because it helps doctors learn if new treatments are promising before they can be tested in larger groups of people. If Ris-Rez proves to be safe and shows some helpful effects, it could potentially become a new treatment option for certain cancers in the future. It's a vital step in discovering new ways to fight cancer.
Key takeaways
- This study is testing a new cancer drug called Ris-Rez.
- It's for people with advanced solid cancers, including those who have had previous treatments.
- The main aims are to check the drug's safety and how it is tolerated.
- Ris-Rez will be given alone or with other standard cancer medicines.
- This is an early-stage study to learn more about the new treatment.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a type of advanced or metastatic solid cancer that has been confirmed by a doctor. If your cancer has already been treated with other medicines, you might still be able to join, depending on how many treatments you've had in the past.
You'll also need to be generally well, meaning you can mostly go about your daily activities, and your body's organs (like your liver and kidneys) need to be working well. The study team will need a recent tissue sample from your cancer if one is available.
There are some reasons why you might not be able to join. For example, if you have ongoing serious side effects from previous treatments, or if you have a primary brain tumour or certain types of brain metastasis that aren't stable. Also, if you've had specific types of previous treatments or certain heart conditions, you might not be eligible. The study team will review all your medical information carefully 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 or metastatic solid cancer?
- Are you able to carry out most daily activities?
- Are your major organs (like liver and kidneys) working well?
- Have you not had certain specific previous treatments or medical conditions?
What does participation involve?
If you decide to take part in this study, the exact details of what you'll need to do, like how often you'll visit the hospital, what tests you'll have, and how long you'll be on the study drug, will depend on which part of the study you join. You'll receive the study drug, Ris-Rez, either by itself or along with other standard cancer medicines, as decided by the study doctors.
Typically, this will involve regular clinic visits for physical exams, blood tests to check your general health and how the drug is affecting you, and scans (like CT scans) to see how your cancer is responding. There will also be appointments to check for any side effects and manage them. The total time you'll be in the study will vary, but you'll have regular follow-up appointments after you stop taking the study drug to monitor your health. All these details will be fully explained before you agree to join.
Potential risks and benefits
Locations (67)
- GSK Investigational SiteVerified postcodeStanford, United States· Recruiting
- GSK Investigational SiteVerified postcodeDenver, United States· Recruiting
- GSK Investigational SiteVerified postcodeNew Haven, United States· Recruiting
- GSK Investigational SiteVerified postcodeFort Wayne, United States· Recruiting
- GSK Investigational SiteVerified postcodeBoston, United States· Recruiting
- GSK Investigational SiteVerified postcodeDetroit, United States· Recruiting
- GSK Investigational SiteVerified postcodeNew Brunswick, United States· Recruiting
- GSK Investigational SiteVerified postcodeMyrtle Beach, United States· Recruiting
- GSK Investigational SiteVerified postcodeNashville, United States· Recruiting
- GSK Investigational SiteVerified postcodeAustin, United States· Recruiting
- GSK Investigational SiteVerified postcodeDallas, United States· Recruiting
- GSK Investigational SiteVerified postcodeSan Antonio, United States· Recruiting
Common questions
What is a 'solid tumour'?
A solid tumour is a type of cancer that forms a solid mass of tissue, rather than cancers that affect the blood, like leukaemia.
What does 'advanced' or 'metastatic' cancer mean?
This means your cancer has either spread from where it started to other parts of your body, or it has grown significantly.
Why is this called a 'Phase 1' study?
Phase 1 is an early stage of research where doctors first test a new drug in people. The main goals are to find a safe dose and understand its side effects, rather than primarily seeing if it cures the disease.
Will I definitely receive the new drug, Ris-Rez?
Yes, if you join this study, you will receive Ris-Rez, either on its own or in combination with other standard cancer medicines.
What does a 'performance status of 0 or 1' mean?
It's a way doctors describe how well you can carry out daily activities. A score of 0 means you're fully active, and 1 means you're restricted in strenuous activity but can do light work.
How to find out more
US GSK Clinical Trials Call Center
Always speak to your GP or specialist before deciding to take part in a study.
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