A Phase 1/2a, First in Human, Open-Label, Multicenter, Dose Escalation Study with Expansion Cohorts to Evaluate the Safety, Tolerability, and Preliminary Activity of LB101 in Subjects with Advanced Solid Tumors
This research study is looking at a new drug called LB101 for people who have advanced solid cancers that have spread to other parts of their body. It's a very early-stage study, meaning it's one of the first times this drug is being given to people. The main goals are to check if the drug is safe, what dose can be given without causing too many side effects, and if there are any early signs that it might help to treat the cancer. This study involves people of all genders aged 18 and older. If you're considering taking part, your doctor can give you more detailed information to help you decide.
At a glance
What is this study about?
This study is about a new potential medicine called LB101. It's designed for people who have advanced solid cancers. These are cancers that started in solid organs (like the breast, lung, or bowel) and have spread to other parts of the body.
Because this is a new drug, the study has two main parts. The first part, called Phase 1, focuses on safety. Researchers want to find out if LB101 is safe for humans, what side effects it might cause, and what is the highest dose that can be given without causing serious problems. The second part, called Phase 2a, builds on this information. Once a safe dose is found, researchers will give the drug to more people to see if there are any early signs that it might help to treat their cancer.
The information gathered from this study is very important. It helps scientists understand how the new drug works and whether it might be a promising treatment option in the future. It's a crucial step in developing new medicines for cancer, offering hope for patients where current treatments might not be enough.
Key takeaways
- This study is testing an experimental new drug, LB101, for advanced solid cancers.
- It's an early-stage study focused on safety, dosage, and initial signs of effectiveness.
- Participants must be 18 or older with advanced solid tumors.
- You will receive the study drug, and monitoring will be regular and close.
- There are potential benefits and risks, and careful discussion with your doctor is essential.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. You must have an advanced solid cancer, meaning a cancer that started in an organ like the breast, lung, or bowel, and has spread to other parts of your body.
Beyond these basic requirements, there are other important health checks that your hospital doctor will need to perform. These checks are designed to make sure the study is a good fit for you and that taking part would be safe given your overall health. For example, they will need to check your general health, how well your organs are working, and what other treatments you might have had.
It's very important to discuss everything with your hospital doctor. They can explain all the detailed requirements and help you understand if this study is suitable for your specific situation. They will ensure you have all the facts to make an informed decision.
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.
- I am at least 18 years old.
- I have been diagnosed with an advanced solid cancer.
- My cancer has spread to other parts of my body.
- I understand this is an early-stage study for a new drug.
- I am physically well enough for a clinical trial (my doctor will check this).
What does participation involve?
If you decide to take part, you'll be given the new study drug, LB101. This is an 'open-label' study, which means both you and your medical team will know you are receiving LB101. The study starts by carefully increasing the dose of the drug for small groups of people to find the safest dose. Once a safe dose is found, more people will receive the drug at that dose.
Throughout the study, you'll have regular hospital visits. During these visits, the medical team will closely monitor your health, perform various tests (like blood tests, scans), and ask you about any side effects you might be experiencing. These checks are vital to understand how your body reacts to the drug and if it's having any effect on your cancer.
The total length of your participation can vary. You'll continue to receive the study drug for as long as it's helping you and you're not experiencing difficult side effects. After you stop receiving the drug, there will be follow-up appointments to make sure your health is stable and to collect final information.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What does 'advanced solid tumors' mean?
It means cancers that started in a solid organ (like the breast, lung, or bowel) and have spread to other parts of your body. It's not suitable for blood cancers.
What is a 'Phase 1/2a' study?
It's an early-stage study that combines two phases. Phase 1 checks how safe a new drug is and what dose can be given, while Phase 2a then starts to look for early signs that the drug might be effective.
Will I know if I'm getting the drug?
Yes, this is an 'open-label' study, meaning both you and your medical team will know you are receiving the study drug LB101. You won't be given a dummy treatment (placebo).
How long will I be in the study?
You'll receive the drug as long as it's helping you and you're not having difficult side effects. There will also be follow-up visits after you stop taking the drug.
Can I stop participating if I want to?
Yes, absolutely. You can withdraw from the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.