Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents
This study is investigating a new cancer drug called ceralasertib. Researchers are giving ceralasertib, often in combination with other anti-cancer medicines, to people with various types of advanced solid cancers, including head and neck, lung, stomach, breast, and ovarian cancers. The main goals are to find the best and safest dose of ceralasertib when given with other treatments, and to carefully monitor for any side effects. The study also aims to see how well these combinations work against the cancer. It's an early-stage study, meaning it's one of the first times these combinations are being tested in people. This helps us learn more about how new treatments might help patients in the future.
At a glance
What is this study about?
This study is looking at a new drug called ceralasertib. It's designed for people who have advanced solid cancers that haven't responded well to standard treatments, or for which standard treatments are no longer an option. The main idea is to see how ceralasertib works, especially when given alongside other well-known cancer treatments, or other new drugs.
The study is divided into different sections, each focusing on ceralasertib with a different partner drug — for example, ceralasertib with carboplatin, or ceralasertib with olaparib. Researchers are starting with small doses and slowly increasing them. This careful approach helps them find the safest and most effective dose for each combination, while keeping a very close eye on patients for any side effects. The study also aims to understand how the body handles ceralasertib and how it might affect the cancer.
Because this is an early-stage study (called Phase 1), it's mainly about safety and finding the right dose. While they will also look for early signs of whether the treatment is working, the primary focus is to make sure the treatment combinations are safe for people to take. This vital step helps pave the way for future studies that might test these treatments more widely if they prove to be safe and show promise.
Key takeaways
- Tests a new cancer drug, ceralasertib, often with other treatments.
- For advanced solid cancers when standard options are limited.
- Main goal is to find safe doses and check for side effects.
- Participants receive ceralasertib, often with another cancer drug.
- Will involve frequent clinic visits for monitoring and tests.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would generally need to be at least 18 years old and have a solid cancer that is advanced and for which standard treatments are no longer suitable, or you have already tried them. Depending on which part of the study you might join, there could be specific requirements about your type of cancer, such as certain advanced stomach, breast, ovarian, specific lung, or head and neck cancers. For some parts, doctors might need to be able to measure your tumour on scans.
There are also some things that would prevent you from joining. For example, if you have a rare condition called ataxia telangiectasia, or if you've already had a drug that works in the same way as ceralasertib. You also couldn't join certain parts if you've had a bad reaction to ceralasertib in the past, or if other medicines in the combination (like olaparib or durvalumab) are not suitable for you. For some specific parts of the study, there are further rules, such as not having had certain previous cancer treatments or having particular genetic changes in your cancer.
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 at least 18 years old?
- Do you have an advanced solid cancer that needs new treatment options?
- Are you able to visit the clinic regularly for tests and monitoring?
- Have you not had a bad reaction to ceralasertib or similar drugs before?
- Are you able to take medicines by mouth as instructed?
What does participation involve?
If you join this study, you will take ceralasertib, which is given by mouth, sometimes along with other cancer medicines. Your dose of ceralasertib may start low and gradually increase. You will have regular visits to the clinic so the medical team can monitor your health very closely. These visits will include blood tests, physical exams, and scans (like CT or MRI) to check on your cancer and any side effects. You might also have special tests, like an ECG to check your heart, especially if you are in the part of the study looking at how food affects the drug.
The entire duration of your participation will depend on how you respond to the treatment and whether you continue to tolerate it well. You will be monitored throughout your treatment and for a period afterwards. The exact frequency of visits and tests will be explained in detail by the study team, but they will be more frequent at the beginning of the study to ensure your safety.
Potential risks and benefits
Locations (28)
- Research SiteVerified postcodeDuarte, United States
- Research SiteVerified postcodeIrvine, United States
- Research SiteVerified postcodeLos Angeles, United States
- Research SiteVerified postcodeLos Angeles, United States
- Research SiteVerified postcodeNewport Beach, United States
- Research SiteVerified postcodeBoston, United States
- Research SiteVerified postcodeNew York, United States
- Research SiteVerified postcodePhiladelphia, United States
- Research SiteVerified postcodeBordeaux, France
- Research SiteVerified postcodeLyon, France
- Research SiteVerified postcodeSaint-Herblain, France
- Research SiteVerified postcodeVillejuif, France
Common questions
What is ceralasertib?
Ceralasertib is a new experimental drug being investigated for cancer treatment. It's often tested in combination with other cancer medicines.
What types of cancer is this study for?
This study is for people with advanced solid cancers, including head and neck, specific lung, stomach, breast, and ovarian cancers, depending on the study part.
Why is this study important?
It helps researchers learn if new combinations of existing and new drugs are safe and effective, potentially opening doors for future cancer treatments.
Will I get the new drug?
Yes, everyone in this study will receive ceralasertib, often in combination with other treatments.
Can I stop participating if I want to?
Absolutely, you can decide to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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