Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer
This research study is for women with advanced ovarian or womb (uterine) cancer that has come back after treatment. We're testing a new drug called RP-6306, given alongside two common chemotherapy drugs, carboplatin and paclitaxel. The main goal is to find the safest and most effective dose of RP-6306 when used in this combination. We're especially interested in cancers that have a particular change in a gene called TP53, as this new drug is designed to work well with such cancers. If you have been told your cancer is advanced, has come back, and you have some specific changes in your cancer cells, this study might be for you. It aims to develop better treatments for these types of cancers.
At a glance
What is this study about?
This study is looking into a new way to treat certain advanced cancers. Specifically, it's for women who have ovarian or womb (uterine) cancer that has returned after previous treatments. These cancers are considered advanced because they may have spread or are difficult to treat with current standard options.
The main focus of this trial is a new investigational drug called RP-6306. An 'investigational drug' means it's still being studied and isn't yet available as a regular treatment. In this study, RP-6306 will be given together with two common chemotherapy drugs, carboplatin and paclitaxel, which you might already be familiar with. The researchers want to see if this combination works better than current treatments.
This is a 'Phase 1' study, which means it's one of the first times this new combination is being tested in people. The first part of the study will help doctors figure out the best and safest dose of RP-6306 to give with carboplatin and paclitaxel. Once that dose is found, more people will join the study to make sure the treatment is safe and to see how effectively it shrinks or stops the cancer from growing. This study is specifically for cancers that have a change in a gene called TP53, as the new drug is designed to target this specific type of cancer.
Key takeaways
- This study is for advanced ovarian or womb cancer that has returned.
- It tests a new drug, RP-6306, with standard chemotherapy.
- It's for cancers with specific 'TP53' gene changes.
- The first goal is to find the safest dose of the new drug.
- Participants must be women aged 18 or older with good general health.
Who may be eligible?
To join this study, you must be a woman aged 18 or over. You need to have advanced ovarian or womb cancer that has come back and has a particular change in the TP53 gene. This means your cancer has specific features that the study treatment is designed to target. It's important that there are no other standard treatments available that would cure your cancer.
Your general health needs to be good enough to take part in the study, and your doctor will check this. You also need to be well enough to receive carboplatin and paclitaxel, as these are part of the study treatment. If you can become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception during and for some time after the study.
There are also some reasons why you might not be able to join. For example, if you've recently had other chemotherapy or radiation treatment, or certain other health conditions, this study might not be suitable for you. Your blood tests and organ function (like your kidneys and liver) need to be within a healthy range specified by the study. Your study doctor will go through all these details with you carefully.
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 a woman aged 18 or older?
- Do you have advanced ovarian or womb cancer that has come back?
- Does your cancer have specific changes in the TP53 gene?
- Are there no other standard cure options for your cancer?
- Are you able to receive carboplatin and paclitaxel chemotherapy?
What does participation involve?
If you join this study, you will receive the new drug RP-6306 along with carboplatin and paclitaxel. Initially, the study will involve finding the best dose, so some participants might start with lower doses that are gradually increased. You'll have regular hospital visits for treatments, blood tests, and scans to monitor your health and how the treatment is working. These visits will be more frequent at the beginning of the study.
The research team will closely monitor you for any side effects. You'll also need to provide tissue samples for molecular testing. If you are a woman who can become pregnant, you will be asked to use highly effective contraception throughout your participation and for 6 months after your last dose of treatment. The total length of your participation will vary, but you will continue treatment as long as it is helping you and you are tolerating it well.
Potential risks and benefits
Locations (1)
- Princess Margaret Cancer CentreVerified postcodeToronto, Canada
Common questions
What is RP-6306?
RP-6306 is a new experimental drug being tested to see if it can help treat certain cancers.
What does 'TP53 mutated' mean?
This means there's a specific change in a gene called TP53 in your cancer cells, which the new drug might target.
Will I still receive standard chemotherapy?
Yes, RP-6306 will be given alongside standard chemotherapy drugs, carboplatin and paclitaxel.
What is a Phase 1 study?
A Phase 1 study is one of the first times a new treatment is tested in people, mainly to find a safe dose and look for side effects.
Can men join this study?
No, this study is specifically for women with ovarian or womb cancer.
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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