A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
This research study is about a new drug called NXP800 for people with advanced forms of cancer. It's happening in two parts. The first part focuses on finding a safe dose of NXP800 for those with different advanced cancers. This involves slowly increasing the dose to see what is well-tolerated. The second part of the study will then look at how effective this drug might be, specifically in people with certain types of ovarian cancer (clear cell and endometrioid) that have a particular genetic change called an ARID1a mutation. The goal is to see if NXP800 could be a helpful treatment option for these specific cancers where current treatments might no longer be working well.
At a glance
What is this study about?
This study is a medical trial looking into a new treatment called NXP800 for people who have advanced cancers. Advanced cancer means the cancer has spread from where it started. The main aim of a study like this is to carefully check if a new drug is safe to use and to understand how well it works, especially for specific types of cancer.
The study has two main stages. In the first stage, called 'Part A', a small group of people with various types of advanced solid cancers will receive NXP800. The doctors will start with a low dose and gradually increase it for different groups of patients. This helps them find the highest dose that can be given safely without causing too many side effects. This safe dosage will then be used in the next part of the study.
In the second stage, 'Part B', the focus shifts to people with certain types of ovarian cancer. Specifically, it will include those with ovarian clear cell cancer or ovarian endometrioid cancer that have a particular genetic change called an ARID1a mutation. These are types of ovarian cancer where standard treatments might not be working as well as hoped. The study will look to see if NXP800 can help shrink these cancers or slow their growth, offering a potential new option for patients.
Key takeaways
- This study is testing a new drug, NXP800, for advanced cancers.
- The first part of the study aims to find a safe dose of NXP800.
- The second part focuses on specific types of ovarian cancer with an ARID1a gene change.
- It's for people whose current treatments are no longer effective or suitable.
- Participation involves receiving the drug and having regular check-ups and scans.
- You can stop taking part in the study whenever you wish.
Who may be eligible?
To be considered for this study, you would generally need to be 18 years old or older and have been diagnosed with an advanced cancer. For the initial phase (Part A), this means your doctors feel there aren't any approved treatments that are working for you, or that such treatments aren't suitable. You would also need to be well enough to take part and have a life expectancy of at least 12 weeks. Your cancer would also need to be measurable, meaning doctors can track its size.
There are also some things that might mean you can't join. For example, if you've recently had other cancer treatments like radiotherapy or chemotherapy, you'd need to wait a certain period before starting. If you have serious side effects from previous treatments that haven't gotten better, you might not be eligible. If you're a woman who could become pregnant, is pregnant, or breastfeeding, you wouldn't be able to join. Men taking part would need to agree to use contraception with a partner who could become pregnant.
For the second part of the study (Part B), which focuses on ovarian cancer, you would specifically need to have ovarian clear cell or endometrioid cancer with a confirmed ARID1a genetic mutation, and your cancer must be resistant to platinum-based chemotherapy.
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 an advanced solid cancer that currently has no effective treatment options?
- Are you generally well enough to take part in a study?
- Can you commit to regular study visits and tests?
- Are you a woman who is not pregnant, breastfeeding, or planning to become pregnant during the study?
- If you are a man, are you willing to use contraception if your partner could become pregnant?
What does participation involve?
If you decide to take part in this study, you would first have a number of tests to check if you are suitable. Once enrolled, you would receive the study drug, NXP800. The way the drug is given and how often would be decided by the study doctors, based on the dose chosen for that part of the study. You would have regular check-ups, which might include blood tests, scans (like MRI or CT scans), and physical examinations. These are to monitor your health, see how your body is reacting to the drug, and check if your cancer is responding. The total duration of your participation in the study would depend on how you respond to the treatment and what the study doctors decide is best for you, but it would involve ongoing visits and assessments for a significant period.
Potential risks and benefits
Locations (22)
- Honor HealthVerified postcodePhoenix, United States
- UC San Diego Health - Moores Cancer CenterVerified postcodeLa Jolla, United States
- University of Colorado Cancer CenterVerified postcodeAurora, United States
- Yale Gynecologic OncologyVerified postcodeNew Haven, United States
- Florida Cancer Specialists SouthVerified postcodeFort Myers, United States
- Mount Sinai Comprehensive Cancer CenterVerified postcodeMiami Beach, United States
- Florida Cancer Specialists Research NorthVerified postcodeSt. Petersburg, United States
- Florida Cancer Specialists Research EastVerified postcodeWest Palm Beach, United States
- University of IowaVerified postcodeIowa City, United States
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States
- Women's Cancer Care AssociatesVerified postcodeAlbany, United States
- The Ohio State University Comprehensive Cancer CenterVerified postcodeColumbus, United States
Common questions
What is NXP800?
NXP800 is a new experimental drug being tested in this study to see if it can treat certain types of advanced cancer.
What does 'advanced cancer' mean?
Advanced cancer means the cancer has spread from where it started, or it is growing in a way that makes it difficult to treat with standard methods.
What is an ARID1a mutation?
An ARID1a mutation is a specific change in the genes of cancer cells. Some ovarian cancers have this particular change, and the study wants to see if NXP800 can help treat these cancers.
Will I know if the drug is working?
The study doctors will conduct regular tests and scans to monitor your cancer and your response to the treatment, and they will share this information with you.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point, and this will not affect your ongoing 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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