A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma.
This research study is looking at a new drug called Fadraciclib for people with advanced solid cancers and lymphoma. These cancers include endometrial, ovarian, breast, and certain types of lymphoma. We want to find out how safe the drug is at different doses, how the body handles it, and if it can help reduce the size of tumors or stop them from growing. This is an early-stage study, meaning it's one of the first times this drug is being tested in a larger group of people. It's open to adults aged 18 and older, regardless of gender. The study will carefully monitor participants for any side effects and track how their cancer responds to the treatment.
At a glance
What is this study about?
This study is investigating a new medication called Fadraciclib for people who have advanced solid cancers or certain types of lymphoma. 'Advanced' means the cancer has grown or spread.
The main goals of the study are to understand how safe Fadraciclib is, how your body processes it, and whether it can shrink tumors or slow down cancer growth. We are particularly interested in a range of cancers, including endometrial cancer, ovarian cancer, breast cancer (such as HER2-negative or triple-negative types, or those that have progressed after other treatments), and different kinds of lymphoma (B-cell and T-cell lymphoma). We also include a 'basket cohort' for other cancer types that we think might respond well to this specific medicine.
This is an early-stage study, combining Phase 1 and Phase 2. In Phase 1, we carefully explore the safety of different doses of Fadraciclib to find the best dose. In Phase 2, we will focus on seeing how many people's tumors shrink or stop growing, called the 'response rate', for each cancer type. We'll also track other important things like how long people live without their cancer getting worse, and how long they continue to respond to the treatment.
Key takeaways
- This study tests a new cancer drug, Fadraciclib, for safety and effectiveness.
- It's for adults with various advanced solid cancers and lymphomas.
- The drug is taken by mouth, with regular clinic visits and tests.
- Potential benefits include access to a new treatment, but risks of side effects exist.
- Participation is voluntary, and you can withdraw at any time.
- It's an early-stage study to learn more about this experimental medicine.
Who may be eligible?
This study is for adults generally aged 18 and over. Both men and women can take part.
You would need to have certain types of advanced solid cancers or lymphoma, as listed in the study. Your cancer must have either progressed after previous treatments or be at an advanced stage where standard treatments are no longer suitable or have stopped working.
There will be other health requirements that your doctor will check. These might include having a certain level of kidney or liver function, and not having other serious health conditions that could make the new medicine unsafe 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.
- Am I 18 years old or older?
- Do I have one of the advanced solid cancers or lymphomas listed (e.g., endometrial, ovarian, breast, certain types of lymphoma)?
- Has my cancer progressed, or are standard treatments no longer an option?
- Am I able to visit the clinic regularly for check-ups and treatment?
- Am I generally well enough to try a new medication?
What does participation involve?
If you join this study, you would receive the study drug, Fadraciclib, by mouth. This will involve regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. The number and frequency of visits will be explained by the study team, but they are typically more frequent at the start of treatment. You will be closely monitored for any side effects. You will continue to take the medicine and attend follow-up appointments as long as you are benefiting from the treatment and not experiencing unacceptable side effects. The total duration of your participation could vary widely, depending on how you respond to the treatment, but you can withdraw at any time.
Potential risks and benefits
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Common questions
What is Fadraciclib?
Fadraciclib is a new experimental drug being tested to treat certain advanced cancers and lymphomas.
What does 'Phase 1/2' mean?
It means the study is in an early stage. Phase 1 checks safety and dosage, and Phase 2 looks at how well the drug works against the cancer.
Which cancers are being studied?
The study includes advanced endometrial, ovarian, breast, colorectal, biliary tract, hepatocellular cancers, and certain lymphomas.
Will I get Fadraciclib, or a placebo?
Everyone in this study will receive Fadraciclib. There is no placebo used in this particular trial.
Can I stop the study at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, without it affecting your 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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