Z0011001-A PHASE 1/2, OPEN-LABEL, MULTI-CENTER STUDY OF ZN-c3 ADMINISTERED IN COMBINATION WITH ENCORAFENIB AND CETUXIMAB IN ADULTS WITH METASTATIC COLORECTAL CANCER
This research study is about finding better treatments for metastatic colorectal cancer, which is bowel cancer that has spread to other parts of the body. We are looking into a new medicine called Azenosertib, alongside two drugs already in use, Encorafenib and Cetuximab. The main goals are to check if this new combination is safe, what side effects it might cause, and if it helps in shrinking the cancer or stops it from growing. This is a multi-centre study, meaning it's happening in different hospitals. It includes two stages: an early stage to find the best and safest dose of Azenosertib, and a later stage to see how well it works for a larger group of people. We'll be closely monitoring participants throughout.
At a glance
What is this study about?
This study is investigating a new way to treat bowel cancer that has spread, often called metastatic colorectal cancer. We know that treatments are constantly improving, and this research aims to build on what we already have. The study focuses on a new drug called Azenosertib, which will be given together with two other medicines, Encorafenib and Cetuximab, that doctors sometimes use for this type of cancer. The hope is that by combining these drugs, we might see better results than with current treatments.
Imagine the study in two main parts, or phases. In the first part, called Phase 1, a small group of people will receive different doses of Azenosertib alongside the other two drugs. The main aim here is to find the safest dose of Azenosertib and understand any side effects. Researchers will be carefully watching to see if any dose causes problems that are too difficult to manage. This step is crucial for patient safety.
Once a safe dose is found, the study moves to Phase 2. Here, more people will receive the combination treatment at the chosen safe dose. The main goal in this phase is to see how effective the treatment is. This includes checking if the treatment helps to shrink the cancer or stops it from growing. Researchers will also continue to monitor for side effects and how the body handles the medicine. The insights gained from this study could lead to new and more effective treatment options for people with metastatic colorectal cancer in the future.
Key takeaways
- This study is for bowel cancer that has spread.
- It tests a new drug (Azenosertib) combined with two existing treatments.
- The study aims to find a safe dose and see how well the treatment works.
- Participants will have regular check-ups and monitoring.
- You can discuss any concerns with the study team at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part in this research.
The most important health requirement is that you must have bowel cancer that has spread to other parts of your body. The researchers will also need to review your past health records and current medical condition to make sure this study is the right fit for you and that taking part would be safe.
There might be other specific health checks and tests you’d need to pass, which your doctor would discuss with you in detail. These are in place to protect your health and ensure the study gets accurate results.
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?
- Have you been diagnosed with bowel cancer that has spread?
- Are you able to attend regular hospital or clinic visits?
- Are you willing to take new study medications as directed?
What does participation involve?
If you decide to take part in this study, you would receive the study medicines: Azenosertib, Encorafenib, and Cetuximab. Your doctors and the study team would give you detailed instructions on how and when to take these. You would have regular visits to the hospital or clinic so the study team can monitor your health very closely.
During these visits, you’d have various assessments. These might include blood tests, urine tests, checks of your heart activity (ECGs), and measurements like your blood pressure and temperature. You might also have scans to check the size of your cancer over time. These checks help the doctors understand how your body is responding to the treatment and if there are any side effects.
Each visit will be an opportunity for you to discuss any concerns or symptoms with the study team. They will also collect information about your overall health and how you’re feeling. The total time you spend in the study would depend on how your treatment progresses and what further monitoring your doctor recommends, but the study team will provide more specific details.
Potential risks and benefits
Locations (5)
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedItaly
Common questions
What kind of cancer is this study for?
This study is for people who have bowel cancer that has spread to other parts of their body.
What new treatment is being tested?
We are testing a new drug called Azenosertib, given together with two other medicines (Encafenib and Cetuximab) that are already used for this type of cancer.
Why are there two phases in this study?
The first phase is to find the safest dose of the new drug. The second phase is to see how well that safe dose works for patients.
What will researchers be looking for?
They will mainly be checking for side effects to ensure the treatment is safe, and also measuring if the cancer shrinks or stops growing.
Do I have to take part in the study if I'm invited?
No, taking part is completely voluntary, and you can choose not to participate or withdraw at any time.
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.