Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
This research is looking into a new experimental drug, AZD5335, for people with advanced solid tumors, including ovarian, lung, and endometrial cancers. The study aims to find out if AZD5335, when used alone or alongside other anti-cancer treatments like Torvutatug samrotecan or Pembrolizumab, is safe for patients and tolerable. Researchers will also be checking to see if this new treatment can help to control or shrink tumors. This is an early-stage study, meaning it’s one of the first times this drug is being tested in humans to understand its effects better. The study is open to both men and women aged 18 and over who have received previous treatments for their cancer.
At a glance
What is this study about?
This study is testing a new medicine called AZD5335, which is an 'antibody-drug conjugate'. This type of drug is designed to specifically target cancer cells, delivering a powerful anti-cancer agent directly to them while aiming to spare healthy cells. Researchers want to find out if AZD5335 is safe and tolerable for people with advanced solid tumors, such as certain types of ovarian, lung, and endometrial cancers. They will also be looking to see if it can help to stop the cancer from growing or even shrink the tumors.
The study is split into two main parts. In the first part, called Phase I, a small group of patients will receive AZD5335 on its own. This helps the doctors find the safest and most effective dose. In the second part, called Phase IIa, AZD5335 will be given in combination with other established cancer treatments like Saruparib or Pembrolizumab, to see how it works alongside them. The goal is to see if combining these treatments can be more effective.
Taking part in studies like this is crucial for developing new cancer treatments. By carefully studying how new medicines work, how they affect patients, and what their benefits and side effects might be, doctors can learn more about how to fight cancer. The information from this study could help future patients by finding new and better ways to treat various types of advanced solid tumors.
Key takeaways
- It's an early-stage study (Phase I/IIa) testing a new drug, AZD5335, for advanced solid tumors.
- The study aims to check if AZD5335 is safe, tolerable, and if it can help fight cancer.
- It's for people aged 18 and over with certain advanced cancers who have had previous treatments.
- AZD5335 may be given alone or with other anti-cancer medicines.
- Participants will have regular health checks and close monitoring.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would need to be 18 years or older and be able to understand and sign the consent forms. You should also be willing to provide tissue samples from your tumor, which helps doctors understand your cancer better and how it might respond to treatment.
Crucially, you would need to have an advanced solid tumor for which you've already had standard treatments, or where your doctor believes this study would be the best next step for you. Your general health and fitness, measured by something called an ECOG performance status, should be good (a score of 0 or 1), meaning you are generally able to carry out most daily activities without too much difficulty. You will also need to have cancer that can be measured by doctors.
Important medical checks will be done to ensure your body, including your organs and bone marrow, is working well enough to take part. Both men and women can participate, and if you are able to have children, you would need to agree to use effective contraception.
- Are you 18 years or older?
- Do you have an advanced solid tumor (like ovarian, lung, or endometrial cancer) that has already been treated?
- Are you generally able to carry out most of your daily activities (good general health)?
- Are you willing to provide tumor tissue samples for study research?
- Are you able to attend regular clinic visits and follow study instructions?
- If you are able to have children, are you willing to use effective contraception during the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll have regular visits to the clinic for assessments, which will include physical exams, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. You'll receive the study medication, AZD5335, either on its own or in combination with other cancer treatments, as determined by the study protocol. The frequency and duration of these treatments will vary depending on the specific part of the study you are in and how you respond. There will also be follow-up appointments after you stop taking the study medication to continue monitoring your health. The total duration of your involvement in the study, from initial screening to full follow-up, could vary, but the main treatment phase would continue as long as the treatment is benefiting you and is tolerable.
Potential risks and benefits
Locations (60)
- Research SiteDuarte, United States· Recruiting
- Research SiteIrvine, United States· Recruiting
- Research SiteLa Jolla, United States· Withdrawn
- Research SiteAurora, United States· Recruiting
- Research SiteLouisville, United States· Terminated
- Research SiteBoston, United States· Recruiting
- Research SiteDetroit, United States· Recruiting
- Research SiteColumbus, United States· Recruiting
- Research SitePortland, United States· Recruiting
- Research SiteProvidence, United States· Recruiting
- Research SiteProvidence, United States· Recruiting
- Research SiteHouston, United States· Recruiting
+48 more sites — see the official record for the full list.
Common questions
What is an 'antibody-drug conjugate'?
It's a clever medicine that combines a targeting antibody with a powerful drug. The antibody finds cancer cells, and then the drug is released directly into them, aiming to kill the cancer while protecting healthy cells.
What does 'advanced solid tumors' mean?
This refers to cancers that have spread beyond where they started or are difficult to treat with standard methods. Solid tumors are cancers that form a lump or mass, like those found in the lung or ovaries.
What is a Phase I/IIa study?
Phase I trials are the first time a new medicine is given to people, primarily to check its safety and find the right dose. Phase IIa studies then look at whether the medicine shows signs of working against the cancer, often in combination with other treatments.
Will I receive other treatments during the study?
Yes, depending on which part of the study you're in, AZD5335 might be given on its own or alongside other established cancer treatments like chemotherapy or other targeted therapies.
What if I decide to stop participating?
You are free to withdraw from the study at any time, for any reason. This decision will not affect your relationship with your doctors or 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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