A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
This research study is looking into a new medicine, AZD8205, as a possible treatment for various advanced cancers, including breast, ovarian, and certain lung cancers, that have spread or come back. The study will test AZD8205 on its own or in combination with other anti-cancer drugs. It's designed to first find the safest and most effective dose of AZD8205, and then see how well it works to treat these cancers. This is called a Phase 1/2a study. Researchers want to understand if this new treatment can offer a different option for patients and help manage their condition.
At a glance
What is this study about?
This research is exploring a new medicine called AZD8205. It's being studied as a potential treatment for several types of cancer that have spread (advanced stage) or returned after previous treatments. These include breast cancer, ovarian cancer, womb (endometrial) cancer, bile duct cancer (biliary tract carcinoma), and a type of lung cancer called squamous non-small cell lung cancer. The study aims to see if AZD8205, either alone or when given with other anti-cancer drugs, can be a safe and effective way to treat these conditions.
The study is divided into two main parts: Phase 1 and Phase 2a. In Phase 1, the main goal is to find the right dose of AZD8205 that is safe for patients and doesn't cause too many side effects. During this phase, doctors will carefully increase the dose until they find the best one. Once that's established, Phase 2a will begin, where more patients will receive AZD8205 (at the dose found in Phase 1) to see how well it works against their cancer and to gather more information about its safety.
Taking part in a study like this means you would be helping doctors and scientists learn more about new ways to fight cancer. Even though it's a new medicine, the study will be carefully monitored by a team of medical professionals. The hope is that this research could lead to new treatment options for people living with these advanced cancers.
Key takeaways
- This study is testing a promising new cancer drug, AZD8205.
- It's for advanced breast, ovarian, uterine, bile duct, and certain lung cancers.
- The study aims to find a safe dose and see how well it works.
- You'll receive active treatment, not a placebo.
- Participation involves regular hospital visits for monitoring and tests.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. You should have a type of advanced cancer that has either come back or spread, such as breast, ovarian, womb, bile duct, or a specific type of lung cancer. The doctors will also consider if you've already had standard treatments for your cancer, or if a research study is the best next step for you.
Before joining, doctors will check certain things through tests. For example, they'll look at your general health, how well your blood, liver, and kidneys are working, and make sure your cancer can be measured. You should also generally feel well enough to manage daily activities.
There are also some specific requirements depending on which part of the study you might join, but generally, having one of the specified advanced cancers and meeting the health requirements mentioned above are key for initial consideration.
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 breast, ovarian, womb, bile duct, or a specific type of lung cancer that has spread or returned?
- Have you already had standard treatments for your cancer, or is a trial like this the right next step for you?
- Are you generally feeling well enough to go about your daily activities (ECOG 0-1)?
- Are your blood, liver, and kidney test results generally within healthy ranges?
- Do doctors say your cancer can be measured on scans?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. This might involve blood tests, scans, and other checks. If you're eligible, you would receive the study medicine, AZD8205, either by itself or with other anti-cancer drugs, depending on your specific situation and which part of the study you join. The medicine would be given regularly, and you would have planned visits to the hospital or clinic for assessments.
These visits would include regular check-ups, blood tests, and scans (like CT or MRI) to see how you are responding to the treatment and to monitor for any side effects. The frequency of visits might be more often at the beginning and then become less frequent as the study progresses. The total duration of your participation would depend on how your cancer responds to the treatment and if any side effects occur. You would be fully supported by the study team throughout your involvement.
Potential risks and benefits
Locations (67)
- Research SiteVerified postcodeDuarte, United States· Completed
- Research SiteVerified postcodeIrvine, United States· Completed
- Research SiteVerified postcodeSanta Monica, United States· Recruiting
- Research SiteVerified postcodeSanta Rosa, United States· Recruiting
- Research SiteVerified postcodeShreveport, United States· Completed
- Research SiteVerified postcodeBaltimore, United States· Recruiting
- Research SiteVerified postcodeBoston, United States· Recruiting
- Research SiteVerified postcodeSt Louis, United States· Recruiting
- Research SiteVerified postcodeAlbuquerque, United States· Recruiting
- Research SiteVerified postcodeCommack, United States· Recruiting
- Research SiteVerified postcodeNew York, United States· Withdrawn
- Research SiteVerified postcodeCharlotte, United States· Recruiting
Common questions
What is AZD8205?
AZD8205 is a new medicine being tested as a possible treatment for advanced cancers, either on its own or with other cancer drugs.
What types of cancer is this study for?
This study is for advanced breast, bile duct, ovarian, womb (endometrial) and a specific type of lung cancer.
What happens in a Phase 1/2a study?
First, doctors find the safest dose of the new medicine (Phase 1), then they check how well it works and gather more safety information (Phase 2a).
Will I get the new medicine or a placebo?
All participants in this study will receive AZD8205, either alone or in combination with other anti-cancer agents. No one will receive a placebo (dummy drug).
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your future medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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