An Open Label, Phase 1/2 Study of HST-1011 Given as Monotherapy and in Combination with an Anti-PD1 Antibody in Patients with Advanced Solid Tumors
This research study is looking at a new medicine, HST-1011, for people who have advanced solid tumors. The study will test HST-1011 in two ways: first, on its own, and then in combination with an existing cancer medicine called Libtayo. This is an early-stage study, meaning it's one of the first times these treatments are being tested in people. The main goals are to find out if the treatments are safe, what side effects might occur, and how they are absorbed and used by the body. Researchers will also be looking for early signs of whether the treatments can help reduce the size of tumors. This information will help decide if these medicines should be tested further.
At a glance
What is this study about?
This research study is focusing on advanced solid tumors, which are cancers that have grown or spread in the body. The study aims to look at a new medicine called HST-1011. This medicine is considered experimental, meaning it's not yet approved for general use. The study will investigate HST-1011 in two different ways: first, by giving it on its own, and second, by giving it alongside another cancer medicine called Libtayo. Libtayo is already approved for some types of cancer and works by helping the body's immune system fight cancer cells.
This is an early-stage study, often called a Phase 1/2 trial. This means it's one of the first times the new medicine is being given to people. The main priorities at this stage are safety and understanding how the medicine behaves in the human body. Researchers will carefully monitor participants for any side effects and track how the medicine is absorbed, processed, and removed from the body. They also want to see if there are any early benefits, like changes in tumor size, to help them decide if the medicine is promising enough for larger studies.
The overall goal is to gather important information about HST-1011. This includes finding the safest dose, understanding how it affects the body's systems, and getting an initial idea of whether it could be an effective treatment for advanced solid tumors. This research is crucial for developing potential new cancer treatments in the future.
Key takeaways
- This study tests a new cancer medicine, HST-1011, for advanced solid tumors.
- It's an early-stage study focusing on safety and how the medicine works.
- HST-1011 will be tested alone and with another medicine, Libtayo.
- Participants will have regular check-ups, blood tests, and other medical assessments.
- The study aims to find a safe dose and see early signs of effectiveness.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 years or older. The study is open to both men and women.
Because this study is for people with advanced solid tumors, you would need to have a confirmed diagnosis of this type of cancer. There will be other specific medical criteria that your doctor will need to check to see if you are a good fit for this particular research.
It's important to discuss your full medical history with the study team. They will review your current health, past treatments, and any other medical conditions to determine if your participation would be safe and appropriate for the study's scientific goals.
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 an advanced solid tumor?
- Are you able to attend regular clinic visits and tests?
- Are you willing to potentially receive an experimental medicine?
- Do you meet other specific health criteria the doctors will explain?
What does participation involve?
If you decide to take part, you will likely have regular visits to the clinic for check-ups and to receive your study medicine. These visits will involve various assessments, such as blood tests, urine samples, physical examinations, measuring your vital signs (like blood pressure and heart rate), and possibly heart recordings (ECGs). These tests help the doctors monitor your health and see how the study medicine is affecting you.
You will receive a study medicine, either HST-1011 on its own or HST-1011 combined with Libtayo. The doses of HST-1011 being tested include 5mg, 10mg, 40mg, and 150mg. You may be in the study for a period of time that includes receiving treatment and then a follow-up period where your health continues to be monitored. The total duration of your involvement would be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is a 'solid tumor'?
A solid tumor is an abnormal mass of tissue that usually doesn't have cysts or liquid areas. Most cancers, like breast, lung, and prostate cancer, form solid tumors.
What does 'advanced' cancer mean?
Advanced cancer means the cancer has grown or spread from where it started to other parts of the body, or it has returned after treatment.
What are 'Phase 1' and 'Phase 2' studies?
Phase 1 studies are the first time a new medicine is tested in people, mainly to check safety and find the right dose. Phase 2 studies continue to look at safety and start to see if the medicine works to treat the condition.
Will I know if I'm getting HST-1011 or HST-1011 with Libtayo?
This is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.
What does a 'monotherapy' mean?
Monotherapy means you receive one treatment (HST-1011) by itself, without it being combined with another medicine for cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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