RecruitingPHASE1INTERVENTIONAL

Study of XB010 in Subjects With Solid Tumors

This research is looking at a new treatment called XB010. We want to understand if it's safe and well-tolerated by the body when given alone or with another approved cancer medicine called pembrolizumab. The study is for adults with advanced solid cancers that are difficult to treat, or when current treatments are no longer working or cause too many side effects. These cancers include certain types of lung, breast, head and neck, and oesophageal cancers. The main goals are to check for any side effects, see how the body uses the new medicine, and find out if it shows any signs of shrinking tumours. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Exelixis

Enrolment target

396

Start

06 Aug 2024

Estimated completion

20 Oct 2027

Locally Advanced or Metastatic Solid Tumors Esophageal Squamous Cell Cancer Head and Neck Squamous Cell Cancer NSCLC (Non-small Cell Lung Cancer)Hormone-receptor-positive Breast Cancer Triple Negative Breast Cancer (TNBC)

What is this study about?

This study is about a new medicine called XB010, designed to treat certain advanced solid cancers that doctors haven't been able to treat effectively with existing medications, or when current treatments cause too many problems. We are testing XB010 in two ways: first, on its own, and then alongside another commonly used cancer drug called pembrolizumab. The main points we want to understand are:

* **How safe is it?** We'll carefully check for any side effects the medicine might cause. * **How does the body handle it?** This involves understanding how the body absorbs, uses, and gets rid of XB010. * **Does it show any promise?** We're looking to see if the medicine can help stop the cancer from growing or even shrink the tumours.

Because this is an early-stage study, we're starting by giving very small doses and slowly increasing them. This helps us find the safest and most effective dose. Once we find that dose, we will then explore its effects in more detail across different types of cancer, including some lung, breast, head and neck, and oesophageal cancers.

Key takeaways

This is an early-stage study (Phase 1) of a new cancer medicine called XB010.
It aims to find a safe dose and look for early signs of effectiveness in advanced solid cancers.
The study involves people with specific types of lung, breast, head and neck, and oesophageal cancers.
XB010 will be given alone or together with another cancer drug, pembrolizumab.
Participation involves regular hospital visits for check-ups and monitoring.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you must be 18 years old or older. You should generally feel well and be able to do most of your normal daily activities, even if you have an advanced cancer. Your major organs, like your liver, kidneys, and blood, need to be working well.

The study is for people with certain solid cancers that have spread, come back, or cannot be removed by surgery. This includes specific types of lung, breast, head and neck, and oesophageal cancers that are advanced or have spread. Importantly, you should not have other effective treatment options available, or the treatments you've tried haven't worked or caused too many problems.

Finally, you need to understand what the study involves and be able to follow the study's instructions. You will also need to sign a form that shows you agree to take part.

Quick self-check

Are you 18 years old or older?
Do you have an advanced solid cancer like certain lung, breast, head and neck, or oesophageal cancers?
Are your doctors saying that other treatments are no longer working or aren't suitable for you?
Are you generally well enough to do most of your daily activities?
Are your major organs (like kidneys, liver) working properly?
Can you understand and follow the instructions for 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 will be given the study medicine, XB010, which might be given alone or with pembrolizumab. The study will start with a dose-finding stage, where you might receive different doses of XB010 to find the safest and most effective amount. This means you would visit the study clinic regularly for check-ups, blood tests, and scans to monitor your health and how the medicine is affecting your cancer. These visits would be more frequent at the beginning.

After the best dose is found, you might continue in the study to see how the medicine works on your specific type of cancer. Throughout the study, you'll have regular appointments, physical examinations, and imaging scans (like CT scans) to track your progress and check for any side effects. The exact duration of your participation will depend on how you respond to the treatment and the study's design. The study team will explain everything in detail, including how long each visit might be and the total length of your time in the study.

Potential risks and benefits

Taking part in a clinical trial like this could potentially offer access to a new treatment (XB010) that isn't available outside the study, especially if other standard treatments haven't worked for you. However, as with any new medicine, there are potential risks, including unknown side effects that could be mild or serious. The study team will carefully monitor you for any problems. You will have full access to all information about the study, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (19)

Exelixis Clinical Site #4
Irvine, United States· Recruiting
Exelixis Clinical Site #19
Los Angeles, United States· Recruiting
Exelixis Clinical Site #10
Washington D.C., United States· Recruiting
Exelixis Clinical Site #18
Orlando, United States· Recruiting
Exelixis Clinical Site #12
Atlanta, United States· Recruiting
Exelixis Clinical Site #15
Chicago, United States· Recruiting
Exelixis Clinical Site #5
St Louis, United States· Recruiting
Exelixis Clinical Site #3
Huntersville, United States· Recruiting
Exelixis Clinical Site #6
Oklahoma City, United States· Recruiting
Exelixis Clinical Site #9
Nashville, United States· Recruiting
Exelixis Clinical Site #1
Austin, United States· Recruiting
Exelixis Clinical Site #7
Dallas, United States· Recruiting

+7 more sites — see the official record for the full list.

Common questions

What is XB010?

XB010 is a new experimental medicine being tested for treating certain advanced solid cancers. It's not yet approved for general use.

What kind of cancers is this study for?

This study is for people with advanced solid cancers that are hard to treat, including certain types of lung, breast, head and neck, and oesophageal cancers.

Will I get XB010 or a placebo (dummy drug)?

Everyone in this study will receive the active study medicine, XB010, either on its own or with pembrolizumab. There is no placebo group in this trial.

What does a 'Phase 1' study mean?

A Phase 1 study is an early stage of testing where the main goal is to find out if a new medicine is safe and what the best dose is, rather than how well it fully treats the disease.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your medical care.

How to find out more

Exelixis Clinical Trials

druginfo@exelixis.com 1-888-EXELIXIS (888-393-5494) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.