Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase 1 Study of PYX-106 in Solid Tumors

Doctors are conducting a very early study, called a Phase 1 trial, to learn more about a new potential medicine named PYX-106. This medicine is being investigated for people who have solid tumours, which are abnormal growths of cells in various parts of the body. The main goal of this first-in-human study is to check if PYX-106 is safe for people and what effects it has on the body. This kind of study helps researchers understand how a new medicine works before it can be tested in larger groups of people. It's an important step in finding new ways to treat cancer, but it's essential to remember that this is a very preliminary stage.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Pyxis Oncology Inc.

Enrolment target

Start

11 Jan 2024

Solid Tumors

What is this study about?

This research study is about a new medicine called PYX-106. It's being tested in people for the very first time. The study focuses on people who have what are called 'solid tumours'. These are often referred to as growths or lumps caused by cancer cells, which can appear in different organs or parts of the body, unlike blood cancers.

The main purpose of this study, known as a Phase 1 trial, is to find out if PYX-106 is safe for people to take and to understand how it affects the body. Doctors will also want to figure out what dose of the medicine is best to use in future studies. Because it's the first time this medicine is being given to humans, the researchers are being very careful.

This kind of early research is really important. It helps scientists learn if a new medicine has the potential to become a useful treatment in the future. It's a stepping stone in the long process of developing new medicines for serious conditions. While it's an exciting step, it's crucial to remember that this is a very early stage of investigation.

Key takeaways

This is a very early study (Phase 1) of a new medicine for solid tumours.
The main goal is to check its safety and how it works in the human body.
It's open to adults aged 18 and over, both men and women.
Participation involves receiving the new medicine and frequent health check-ups.
There are potential benefits and risks; you can leave the study anytime.
It helps researchers find new potential treatments for the future.

Who may be eligible?

To join this study, you would need to be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to take part if they meet the other requirements.

This study is open to both men and women. The most important thing is that you have a solid tumour. The researchers will have specific details about your health and medical history that they need to check to make sure the study is right for you, and that you can safely take the new medicine.

It's important to talk to your doctor and the research team, as they will carefully review your medical information to see if you are a good fit for this particular study.

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 diagnosis of a solid tumour?
Are you able to attend regular hospital or clinic appointments?
Are you willing to take a new, experimental medicine?
Are you able to understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, PYX-106. Because this is a very early study, you would have regular visits to the hospital or clinic. These visits would involve various check-ups, like blood tests, physical examinations, and possibly scans, to monitor your health and how the medicine is affecting you. The doctors and nurses would be closely watching for any changes. The total length of your participation would depend on the study plan, but early-stage trials often involve frequent monitoring for a certain period, followed by follow-up appointments.

Potential risks and benefits

Taking part in a study like this comes with potential benefits and risks. The main potential benefit is that you could be among the first to receive a new medicine that might help your condition, although this is not guaranteed, especially in early studies. Potential risks include experiencing side effects from the new medicine, which could range from mild to more serious, and some effects might not be known yet. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Belgium

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. It can be cancerous or non-cancerous and can grow in various parts of the body.

What does 'Phase 1' mean for a clinical trial?

Phase 1 is the very first stage of testing a new medicine in humans. The main goals are to check if it's safe, find the right dose, and understand how it works in the body.

Will this medicine cure my cancer?

It's too early to say if PYX-106 will cure cancer. This study is mainly focused on safety and understanding the medicine, not on finding a cure. A cure is not expected at this stage.

Will I know if I'm getting the actual medicine?

In a Phase 1 study like this, everyone usually receives the new medicine to help researchers understand its effects. You would not receive a placebo (dummy drug) in most Phase 1 trials.

Does it cost anything to join the study?

Taking part in a clinical trial usually means the study medicine and any study-related tests are provided at no cost to you. Travel costs may or may not be covered; you should ask the research team about this.