A PHASE 1/2 STUDY OF ONCOBAX®-AK ADMINISTERED IN COMBINATION WITH IMMUNOTHERAPY TO PATIENTS WITH ADVANCED SOLID TUMORS
This research study is investigating a new medication, Oncobax®-AK, when used together with several commonly used immunotherapy drugs. It's designed for patients with advanced non-small cell lung cancer or kidney cancer where standard treatments might not be working as well as hoped. This trial is divided into two main parts. The first part (Phase 1) is mostly about finding the safest dose of Oncobax®-AK and understanding any side effects when combined with other medicines. The second part (Phase 2) will then look more closely at how effective this new combination therapy might be in shrinking tumours. This is considered an early-stage study, meaning it's among the first times this new drug combination is being studied in people.
At a glance
What is this study about?
This study is a clinical trial, which is a carefully planned research study to test new treatments in people. The main aim of this particular study is to see if a new drug called Oncobax®-AK, when given together with existing cancer medicines known as immunotherapies, could be helpful for people with advanced non-small cell lung cancer (a common type of lung cancer) or kidney cancer. Immunotherapies are treatments that help your body's own immune system fight cancer.
The study is split into two phases. The first phase (Phase 1) is like a careful introduction. During this phase, doctors will give different doses of Oncobax®-AK to small groups of patients to find the dose that is safest and has the fewest side effects when used with the immunotherapy drugs. This step is very important to make sure future patients get the best and safest possible treatment.
Once a safe dose is found, the study moves to the second phase (Phase 2). Here, more patients will receive the combination treatment. The doctors will then be looking to see early signs of whether the treatment is effective, for example, if it shrinks tumours or stops them from growing. They will also continue to monitor for any side effects. These kinds of studies are a crucial step in developing new cancer treatments.
Key takeaways
- This study is testing a new drug, Oncobax®-AK, for advanced lung or kidney cancer.
- It combines Oncobax®-AK with existing immunotherapy drugs.
- The early stages focus on finding the safest dose and understanding side effects.
- Later stages will check for early signs of how well the treatment shrinks tumours.
- It's open to adults aged 18 and over, with specific types of advanced cancer.
- Participation involves regular clinic visits for treatment and monitoring.
Who may be eligible?
To join this study, you need to be at least 18 years old, and it's open to both men and women. The specific type of cancer you have must be advanced non-small cell lung cancer or kidney cancer.
There will be other important health checks that your study doctor will need to do to make sure the treatment is suitable and safe for you. These might include reviewing your general health, past medical history, and any other medications you are currently taking.
It's worth remembering that these studies often have strict guidelines to ensure the safety of participants and the accuracy of the research. Your doctor will be able to tell you if you meet all the necessary requirements.
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 non-small cell lung cancer?
- OR do you have a diagnosis of advanced kidney cancer?
- Are you able to attend regular clinic appointments for treatment and check-ups?
- Are you willing to have tests, such as blood tests and scans?
What does participation involve?
If you decide to take part, you would receive the new study drug, Oncobax®-AK, along with one of the approved immunotherapy drugs (like Libtayo, Opdivo, Yervoy, Tecentriq, or Keytruda). These drugs are usually given through a drip into your arm (an infusion). You would have regular visits to the clinic for these treatments and check-ups.
During your visits, the study team would closely monitor your health. This includes checking for any side effects, taking blood tests, having scans to see how your cancer is responding, and discussing any symptoms you might have. The exact number of visits and the total length of time you participate would depend on how you respond to the treatment and the study plan, but you would be fully informed about the schedule beforehand. There will also be a follow-up period after your treatment finishes.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
This study is for people with advanced non-small cell lung cancer or advanced kidney cancer.
What is Oncobax®-AK?
Oncobax®-AK is a new medication being tested in combination with existing immunotherapy drugs for cancer treatment.
What are immunotherapies?
Immunotherapies are treatments that help your body's own immune system fight cancer. Examples used in this study include Libtayo, Opdivo, Yervoy, Tecentriq, and Keytruda.
What does 'Phase 1' and 'Phase 2' mean?
Phase 1 primarily checks for the safest dose and side effects, while Phase 2 looks at how well the treatment works after a safe dose is found.
Will I get the new drug, or a dummy treatment?
In this study, everyone will receive the new drug combination. It's not a study where some people get a placebo (dummy treatment).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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