An Open-label, Multicenter, Phase 1a/1b Study to Evaluate the Safety and Anti-tumor Activity of TT125-802 in Combination With Adagrasib, Osimertinib or Docetaxel in Patients with Advanced NSCLC
This research is testing a new treatment called TT125-802 for people who have advanced non-small cell lung cancer (NSCLC). This is a type of lung cancer that has spread. The study will try TT125-802 alongside other common cancer medicines like Adagrasib, Osimertinib, or Docetaxel. It's an 'open-label' study, meaning everyone involved will know which treatment they are receiving. This is an early phase (Phase 1) study, which means the main goals are to check how safe the new drug combination is and to see if it shows any signs of helping to reduce the cancer. Participants will be adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is trying to find new ways to treat advanced non-small cell lung cancer (NSCLC). This type of cancer has often spread to other parts of the body, making it harder to treat. Doctors are testing a new medicine called TT125-802. They want to see if it can be safely given together with other treatments that are already used for lung cancer, such as Adagrasib, Osimertinib, or Docetaxel. This is important because combining treatments can sometimes work better than using just one.
The main aim of this research is to check the safety of these new drug combinations. When a new drug is first given to people, doctors need to carefully watch for any side effects and find the right dose. They will also be looking to see if the new medicine helps to shrink the tumours or stop them from growing, which is called 'anti-tumour activity'. This is an early-stage study, meaning it's one of the first times this new drug is being tested in a larger group of people.
Because it's an 'open-label' study, everyone involved – the patients, doctors, and nurses – will know which specific combination of medicines each person is receiving. This helps the researchers understand the effects better. While the focus is on safety, any positive effects on the cancer will also be carefully noted, helping to decide if this treatment should be studied further in the future.
Key takeaways
- It's a study for advanced non-small cell lung cancer (NSCLC).
- It tests a new drug (TT125-802) with existing cancer medications.
- The main goals are to check safety and see if it helps reduce cancer.
- It's an 'open-label' study, so everyone knows which treatment they receive.
- Participation involves regular hospital visits for checks and tests.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have advanced non-small cell lung cancer (NSCLC).
There will be other specific health requirements that your doctor will check. These might include how well your organs are working, if you have certain other health problems, or if you've had specific treatments recently. These rules are in place to make sure the study is as safe as possible for everyone involved and to ensure the results are clear.
Your doctor will discuss all the detailed requirements with you to see if this study could be a suitable option. It's important to understand that not everyone with advanced NSCLC will be able to join, as the rules are quite strict for early-stage studies.
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 non-small cell lung cancer (NSCLC)?
- Are you able to attend regular hospital appointments?
- Are you willing to have blood tests and scans as part of the study?
- Are you comfortable with the possibility of new or unknown side effects?
What does participation involve?
If you decide to take part, you would receive the study medication (TT125-802) along with one of the other cancer drugs (Adagrasib, Osimertinib, or Docetaxel). The doctors will give you clear instructions on how and when to take your medicines.
Throughout the study, you would have regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks. This would involve physical exams, blood tests, and scans (like CT or MRI scans) to monitor your health, check for side effects, and see how the treatment is affecting your cancer. These assessments are crucial for understanding how the new drug works.
After you finish taking the study medication, you would likely have some follow-up visits. These continue to check on your health and any long-term effects of the treatment. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What type of cancer is this study for?
This study is for advanced non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread.
What does 'Phase 1' mean?
Phase 1 means this is an early stage study to mainly check if the new drug combination is safe and to find the right dose. Doctors also look for initial signs that it's working.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, so you and your doctors will know exactly which medicines you are receiving.
How long will I be in the study?
The full length of your involvement, including follow-up, will be clearly explained by the study team before you start.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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