A first-in-human, phase 1/2, multicenter, open-label, dose escalation, confirmation and expansion study to evaluate the safety, pharmacokinetics and antitumor activity of TH9619 in subjects with advanced solid tumors (ODIN)
This study is looking into a new treatment called TH9619 for advanced solid cancers, cancers that have spread or can't be removed by surgery. It's a 'first-in-human' study, which means it's the very first time this drug is being tested in people. Researchers want to find out if TH9619 is safe, what the right dose is, how it moves through the body, and if it can shrink certain types of tumours. The drug works by targeting specific processes in cancer cells, aiming to damage them while leaving healthy cells alone. This study focuses on people who have already tried standard cancer treatments.
At a glance
What is this study about?
This research study, called ODIN, is trying out a new medicine called TH9619 for people who have advanced solid tumours. This means your cancer has spread or can't be completely removed by surgery. Researchers want to see if TH9619 can help when other standard treatments haven't worked or are no longer an option. It's a very early-stage study, meaning it's the first time this drug is being given to people, so we're still learning a lot about it.
The main goals are to check if TH9619 is safe, understand how your body handles the medicine (like how quickly it's absorbed and removed), and see if it has any effect on the cancer. The drug is designed to specifically target cancer cells by blocking certain enzymes they need to survive. This process aims to damage the cancer cells and cause them to die, without harming healthy cells. Your participation could help us understand if this new approach could lead to future treatments for cancer.
The study is divided into two main parts. The first part is about finding the safest and most effective dose of TH9619. This means starting with a low dose and gradually increasing it in different groups of people until they find the dose that works best without causing too many problems. The second part will then treat more people with this chosen dose to collect more information on how well it works and if it's safe over a longer period.
Key takeaways
- This is a first-time human study of a new cancer drug, TH9619.
- It's for people with certain advanced solid cancers whose previous treatments haven't worked.
- The study aims to find a safe dose and see if the drug fights cancer.
- TH9619 works by targeting specific weaknesses in cancer cells.
- You'll receive weekly infusions and have regular monitoring.
- Participation may not directly benefit you, but could help future patients.
Who may be eligible?
You might be able to join this study if you are 18 years or older and have certain types of advanced solid cancer, such as bowel (CRC), head and neck (HNSCC), lung (NSCLC, but not certain types), or stomach cancer. It's important that your cancer has already been treated with at least one other type of standard chemotherapy and has started to grow again.
There are also some health checks you'll need to pass, like having good general health and certain blood test results. You'll need to be able to have biopsies (small tissue samples taken) and a good general fitness level. Your doctor will carefully review all the requirements to see if this study is suitable for you.
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 bowel, head & neck, lung (certain types), or stomach cancer?
- Have you already had at least one chemotherapy treatment for your advanced cancer and it has started to grow again?
- Are you generally well and fit enough for daily activities?
- Are you willing to have small tissue samples (biopsies) taken?
What does participation involve?
If you decide to join, you would receive the study drug, TH9619, as a drip into your vein (infusion) once a week for three weeks, followed by one week without treatment. This four-week period is called a 'cycle.' You'll continue these cycles until your cancer starts to get worse, you experience side effects that are too difficult to manage, or your study doctor feels it's no longer the best option for you.
Throughout the study, you'll have regular hospital visits for blood tests, check-ups, and scans to see how you're responding to the treatment. You may also need to have biopsies. After you stop receiving the treatment, we will continue to keep in touch to check on your health and gather information about your cancer and survival for up to two years.
Potential risks and benefits
Locations (1)
- Newcastle UniversityApproximateNewcastle-upon-Tyne, England
Common questions
What does 'first-in-human' mean?
It means this is the very first time this new drug, TH9619, is being given to people. Researchers are cautiously trying it out after extensive lab and animal tests.
What is the main goal of this study?
The main goals are to find out if the drug TH9619 is safe, what the best dose is, how it works in the body, and if it can help treat advanced cancer.
How does the new drug, TH9619, work?
TH9619 works by blocking certain processes that cancer cells need to grow and survive, causing damage to the cancer cells while aiming to leave healthy cells unaffected.
What kind of cancers are included in this study?
This study is for specific types of advanced solid cancers, including bowel, head and neck, lung (certain types), and stomach cancer, where other treatments haven't worked.
Will I have regular check-ups during the study?
Yes, you will have regular hospital visits for blood tests, scans, and check-ups to monitor your health and how the treatment is working.
How to find out more
Ana Slipicevic
Always speak to your GP or specialist before deciding to take part in a study.
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