RecruitingPHASE1INTERVENTIONAL

A Study of PYX-201 in Advanced Solid Tumors

This clinical trial is looking into a new medicine called PYX-201 for people who have advanced solid cancers that have come back or spread. The main goals are to work out the safest and most effective dose of PYX-201 and to see if it can shrink tumours when given on its own. It's a 'Phase 1' study, which means it's one of the first times this medicine is being tested in humans. The researchers want to learn more about how the drug works, what side effects it might have, and if it could be a helpful treatment option in the future. The study is open to adults over 18 with specific types of advanced solid tumours.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Pyxis Oncology, Inc

Enrolment target

330

Start

14 Mar 2023

Estimated completion

01 May 2027

Solid Tumor Advanced Solid Tumor

What is this study about?

This study is a clinical trial, which means it's a carefully controlled research study involving people. The main purpose of this particular trial is to test a new medicine called PYX-201. This medicine is designed for adults who have advanced solid tumours – these are cancers that have either returned after treatment or have spread to other parts of the body. The research team wants to find the best and safest dose of PYX-201. They also want to see how well it works on its own to shrink tumours.

Because this is a very early-stage (Phase 1) study, the focus is on understanding the new medicine better. This includes learning about any side effects, how the body handles the medicine, and seeing if there are early signs that it could be an effective treatment. It's an important step in developing new cancer treatments, but it's not yet known if PYX-201 will become a standard treatment.

Taking part in a study like this could help doctors learn more about cancer and develop new ways to treat it in the future. While there's no guarantee of benefit for you personally, your participation could be very valuable to medical science.

Key takeaways

This study tests a new medicine (PYX-201) for advanced solid cancers.
It's a Phase 1 study, focusing on finding a safe dose and understanding side effects.
Participation involves receiving the medicine and close medical monitoring.
Open to adults over 18 with specific advanced solid tumours.
Both potential benefits and risks need to be carefully considered.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would generally need to be an adult over 18 years old. You should have a solid tumour that has been confirmed by a doctor, and it should be advanced, meaning it has spread or come back. This includes specific types of breast cancer, head and neck cancer, and other solid tumour types, usually after you’ve already had some other treatments.

To ensure your body can safely handle the new medicine, doctors will check your general health. This includes making sure your heart, kidneys, liver, and blood are working well. You must also be able to move around fairly easily, as assessed by a quick check from the doctor. They’ll also need a tumour sample, either a fresh one or one from an earlier biopsy, and your tumours must be measurable by scans.

There are also reasons why you might not be able to join. For example, if you have had certain other cancers, current active infections, or serious heart problems within the last six months, you might not be eligible. If you have known active hepatitis B or C, or HIV, or if you’ve had a transplant, you also can’t take part. These rules are in place to keep participants safe and to make sure the study results are clear.

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 a solid cancer that has spread or come back?
Are you generally well enough to do most daily activities?
Have your doctor confirmed your heart, liver, and kidney functions are good?
Do you have a tumour that can be measured on a scan?
Are you free from certain active infections like Hepatitis B/C or HIV?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the experimental medicine, PYX-201. The study team will regularly monitor your health very closely with various tests, including blood tests, heart checks, and scans to see how your tumour is responding. You will have regular appointments at the clinic for these assessments.

The study will also involve providing a tumour sample, either a fresh one or an older one you may have had. The total length of your participation would depend on how you respond to the treatment and the study plan, but you will be kept informed throughout.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might not directly benefit from this particular study, as it's primarily designed to learn about a new medicine. However, you would receive very close medical attention during the trial, and the medicine might help control your cancer. Potential risks include side effects from the new medicine, which are not fully known yet, and the discomfort of clinic visits and medical procedures. You will be fully informed about all known risks before you decide to join, and you always have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

HonorHealth Research Institute
Verified postcode
Scottsdale, United States· Recruiting
Ronald Reagan UCLA Medical Center
Verified postcode
Los Angeles, United States· Recruiting
SCRI - HealthOne Denver
Verified postcode
Denver, United States· Recruiting
SCRI - Florida Cancer Specialists
Verified postcode
Sarasota, United States· Recruiting
Winship Cancer Institute, Emory University
Verified postcode
Atlanta, United States· Recruiting
University of Chicago Medicine
Verified postcode
Chicago, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
University of Cincinnati Medical Center
Verified postcode
Cincinnati, United States· Recruiting
University of Pennsylvania, Abramson Cancer Center
Verified postcode
Philadelphia, United States· Recruiting

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that usually doesn't contain cysts or liquid areas. Most cancers are solid tumours, like breast cancer or lung cancer.

What does 'advanced' cancer mean?

Advanced cancer means that the cancer has either spread from where it started to other parts of the body, or it has come back after previous treatment.

What is a 'Phase 1' study?

A Phase 1 study is the first stage of testing a new medicine in people. Its main goals are to find a safe dose, understand how the body handles the medicine, and look for any early signs of benefit and side effects.

Will I have to have a new biopsy?

The study asks for a tumour sample. This can either be a sample collected from when your cancer was first diagnosed or, if needed, a new small procedure to collect a fresh sample.

Can I stop participating in the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Pyxis Oncology Clinical Trials Team

clinicaltrials@pyxisoncology.com (339) 545 8252 Official trial record

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