A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
This study is investigating a new medicine, GSK5733584, for individuals with advanced solid tumours that have not responded well to standard treatments. The main goals are to check if the medicine is safe and if people can tolerate it without too many side effects. Researchers will also be looking at how the medicine moves through the body and how quickly it's cleared, which helps them understand the right dose. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people. It's hoped that understanding GSK5733584 better will help in developing new ways to treat these types of cancers in the future. Participants will be closely monitored throughout the study.
At a glance
What is this study about?
This study is focused on a new investigational medicine called GSK5733584. An investigational medicine means it's not yet approved for general use, and we're still learning about it. The main purpose of this study is to find out if GSK5733584 is safe and if people can tolerate it without experiencing serious side effects. Researchers will also be studying how the medicine behaves in the body, such as how much gets into the bloodstream and how long it stays there, at different dose levels. This helps them work out the best and safest dose.
The study is for people who have advanced solid tumours. These are cancers that have grown to a stage where they may have spread to other parts of the body, and they haven't responded well to standard treatments that are usually given. The researchers are hoping to learn if GSK5733584 could be a potential new treatment option for these types of cancers in the future. It's important to remember that this is an early-stage study (Phase 1), which means it's primarily about understanding the medicine's safety and how the body handles it, rather than directly checking if it shrinks tumours, although they will be looking at this too.
By taking part, individuals contribute to our understanding of this new medicine. The information gathered will be crucial for deciding whether to continue developing GSK5733584 and potentially move it into later-stage studies with more participants. Every step in this research helps move us closer to finding new and better ways to treat cancer.
Key takeaways
- This study is testing a new medicine (GSK5733584) for advanced solid tumours.
- The main goals are to check if the medicine is safe and how the body handles it.
- It's an early-stage study, so new information is still being gathered.
- Only adults aged 18 and over with specific advanced cancers are eligible.
- Participation involves regular hospital visits, medicines, and tests.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is for adults aged 18 or older who have advanced solid tumours. This means your cancer has either spread or can't be removed with surgery, and standard treatments haven't worked or you couldn't tolerate them.
They are specifically looking for people with certain types of advanced ovarian cancer (including fallopian tube or primary peritoneal cancer) that has resisted platinum-based chemotherapy, or advanced endometrial cancer. For these specific cancers, there are also requirements about how many previous treatments you've had and if you've used certain other medicines like bevacizumab, mirvetuximab soravtasine, or PARP inhibitors, or specific platinum and PD(L)-1 inhibitor therapies.
To be considered, you'll also need to have at least one measurable tumour spot that doctors can track. They will also need a sample of your tumour tissue, either a new biopsy or an older one, to check for a specific marker called B7-H4.
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 a diagnosis of advanced solid cancer that has not responded to standard treatments?
- For ovarian/fallopian/peritoneal cancer: Has your cancer returned within 6 months of platinum chemotherapy?
- For endometrial cancer: Have you had between 1 and 3 lines of prior treatment, including platinum and PD(L)-1 inhibitor therapy?
- Do you have at least one tumour that can be measured and tracked by doctors?
What does participation involve?
If you take part in this study, you will receive doses of the investigational medicine, GSK5733584, which will be given by injection. The study involves a number of hospital visits, especially at the beginning, so that the study team can closely monitor your health and how you are responding to the treatment. They will also take blood and urine samples regularly to check the levels of the medicine in your body and to look for any side effects. You will have scans and other tests to see how your tumour is affected by the treatment.
The exact number and timing of visits will depend on which part of the study you are in and how you respond to the medicine. The study doctors and nurses will explain all the procedures in detail before you decide to take part. The overall duration of your participation in the study will vary, but you will be told how long you are expected to be involved. You will also have regular check-ups even after you stop receiving the study medicine.
Potential risks and benefits
Locations (65)
- GSK Investigational SiteVerified postcodeBirmingham, United States· Recruiting
- GSK Investigational SiteVerified postcodeFountain Valley, United States· Recruiting
- GSK Investigational SiteVerified postcodeSanta Rosa, United States· Recruiting
- GSK Investigational SiteVerified postcodeLake Mary, United States· Completed
- GSK Investigational SiteVerified postcodeOrlando, United States· Recruiting
- GSK Investigational SiteVerified postcodeFairway, United States· Recruiting
- GSK Investigational SiteVerified postcodeBoston, United States· Recruiting
- GSK Investigational SiteVerified postcodeBoston, United States· Recruiting
- GSK Investigational SiteVerified postcodeDetroit, United States· Recruiting
- GSK Investigational SiteVerified postcodeGrand Rapids, United States· Recruiting
- GSK Investigational SiteVerified postcodeMinneapolis, United States· Recruiting
- GSK Investigational SiteVerified postcodeMineola, United States· Recruiting
Common questions
What is a 'solid tumour'?
A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Many types of cancer form solid tumours.
What does 'advanced' cancer mean?
Advanced cancer means the cancer has either spread from where it started to other parts of the body (metastatic) or cannot be completely removed by surgery (unresectable).
What is an 'investigational medicine'?
An investigational medicine is a drug that is still being studied and has not yet been approved for general use by health authorities.
Why do they need a tumour tissue sample?
Researchers need a sample of your tumour to test for specific markers, like B7-H4, which helps them understand if the medicine might work better for certain types of cancer cells.
Will I know if the medicine is helping my cancer?
The study team will regularly check your tumour with scans and other tests. They will discuss your results with you, but the main aim of this early study is to check safety and how the medicine behaves in the body.
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.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.