Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
This is an early-stage clinical trial (Phase 1) looking into a new experimental medicine called XmAb541. It's designed for people in the UK and US who have advanced forms of ovarian cancer, endometrial cancer, or certain germ cell tumours that have continued to grow despite previous treatments. The main goals are to find out if XmAb541 is safe for people to take, and to work out the best dose that can be given without causing too many side effects. Researchers will also be watching to see if the medicine has any effect on the cancer. Since it's a new medicine, this study is crucial for understanding how it works and if it could be a helpful treatment in the future.
At a glance
What is this study about?
This study is a clinical trial, which is a type of research study that tests new medicines or treatments in people. The medicine being tested here is called XmAb541. It's considered an investigational drug because it's still in the early stages of development and isn't yet available as a standard treatment. The main aim of this particular study is to see if XmAb541 is safe to use and if people can tolerate it well. Researchers will also be trying to find the best dose of the medicine – one that is strong enough to potentially help but doesn't cause too many unwanted side effects.
This trial is specifically for people who have certain types of advanced cancer, including ovarian cancer, endometrial cancer, and germ cell tumours. These are cancers that have either spread, come back, or haven't responded to standard treatments. By checking for safety and the right dose, this study helps decide if XmAb541 should be tested in larger studies in the future.
Doctors will also be carefully monitoring participants to see if XmAb541 has any effect on their tumours. This means they will look to see if the cancer shrinks, stops growing, or changes in other ways. This information is really important for understanding if the medicine could be a promising new treatment option for these cancers in the future. Remember, participating in a clinical trial is a personal decision, and it's always best to discuss it thoroughly with your own doctor.
Key takeaways
- This is an early-stage study (Phase 1) for a new medicine called XmAb541.
- It aims to find out if XmAb541 is safe and to determine the best dose for people with certain advanced cancers.
- The study is for people with advanced ovarian, endometrial, or germ cell tumours that haven't responded to other treatments.
- Participation involves regular hospital visits, tests, and taking the study medicine.
- You have the right to withdraw from the study at any time without affecting your ongoing medical care.
Who may be eligible?
To be able to join this study, there are some important criteria you need to meet. Generally, participants must be at least 18 years old. However, in the US, people aged 15 and over with germ cell tumours might also be able to join. Your cancer must have a specific marker called CLDN6+. You also need to have been diagnosed with ovarian, fallopian tube, peritoneal, endometrial cancer, or a germ cell tumour that has continued to grow despite earlier treatments.
Doctors will also check that you are generally well enough to take part. This includes having good overall health, your body's organs (like your liver, kidneys, and bone marrow) working properly, and being able to manage daily activities.
There are also some reasons why you might not be able to join. For example, if you have certain untreated brain tumours, specific autoimmune diseases (where your immune system attacks healthy cells), or conditions that need strong medicines to suppress your immune system. You also can't take part if you have active hepatitis B or C, or significant heart, lung, or stomach problems.
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 at least 18 years old (or 15 for certain germ cell tumours in the US)?
- Does your tumour have a specific marker called CLDN6+?
- Do you have advanced ovarian, endometrial, or germ cell cancer that hasn't responded to previous treatments?
- Are you generally well and able to manage your daily activities?
- Do you NOT have untreated brain tumours, active autoimmune disease, or specific liver, kidney, or heart problems?
What does participation involve?
If you decide to take part in this study, you will be given the experimental medicine called XmAb541. The study is designed to be an early-stage trial, so it will involve regular visits to the hospital or clinic. During these visits, you will have various tests to check your health, how the medicine is affecting your body, and whether your cancer is responding. These tests might include blood samples, physical examinations, and scans.
The specific number of visits and tests will vary depending on which part of the study you are in and how you respond to the treatment. You will receive the study medicine for a period of time, and the doctors will closely monitor you for any side effects. After you finish receiving the study medicine, there will likely be a follow-up period where doctors will continue to check on your health and the status of your cancer. The total duration of your participation, including follow-up, will be explained in detail by the study team, but generally, it involves commitment for several months.
Potential risks and benefits
Locations (27)
- City of HopeVerified postcodeDuarte, United States· Recruiting
- Stanford UniversityVerified postcodePalo Alto, United States· Recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- Winship Cancer Institute, Emory UniversityVerified postcodeAtlanta, United States· Recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterVerified postcodeIndianapolis, United States· Recruiting
- Karmanos Cancer InstituteVerified postcodeDetroit, United States· Recruiting
- University of MinnesotaVerified postcodeMinneapolis, United States· Recruiting
- The John Theurer Cancer Center at Hackensack University Medical CenterVerified postcodeHackensack, United States· Recruiting
- Icahn School of Medicine at Mount SinaiVerified postcodeNew York, United States· Recruiting
- Montefiore Einstein Comprehensive Cancer CenterVerified postcodeThe Bronx, United States· Recruiting
Common questions
What is a 'Phase 1' study?
A Phase 1 study is the first time a new medicine is tested in people. Its main goal is to check if the medicine is safe and to find the best dose, rather than primarily seeing if it cures the disease.
What kind of cancer does this study focus on?
This study is for people with advanced ovarian cancer, endometrial cancer, or certain germ cell tumours that have not responded to previous treatments.
Will I get better if I join this study?
It's not guaranteed that you will get better. This is an early study to see if the medicine is safe and what dose to use. While it might help, it might also have no effect or cause side effects.
What is XmAb541?
XmAb541 is a new, experimental medicine that is being tested in this study. It is not yet an approved treatment, and doctors are trying to learn more about how it works.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your medical care in any way.
How to find out more
XmAb541-01 Central Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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