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

DT-9081 trial in participants with advanced solid tumours.

This study is looking for adults aged 18 and over who have advanced solid tumours. This means cancers that cannot be removed by an operation, have come back, or have spread to other parts of the body. The main aim of the study is to test a new medicine called DT-9081 for the very first time in people. This is an early-stage study, called a Phase 1 trial. Doctors want to find out if DT-9081 is safe, what dose can be given, and if it has any effect on the cancer. Taking part could help improve treatments for future patients with similar cancers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Domain Therapeutics

Enrolment target

Start

05 Sep 2024

Participants with advanced ( unresectable recurrent or metastatic) solid tumours

What is this study about?

This study, called the DT-9081 trial, is for people who have advanced solid tumours. "Advanced" means the cancer might have spread, come back after treatment, or can't be completely removed by surgery. Solid tumours are cancers that form a lump or mass, like breast cancer, lung cancer, or colon cancer, rather than blood cancers like leukaemia.

The main goal of this particular study is to test a new medicine called DT-9081. This is the very first time this medicine will be given to people. It's a key early step in developing new treatments. Doctors need to carefully check if the medicine is safe, what side effects it might cause, and what dose can be given safely. They will also be looking to see if there's any sign that it could help to treat the cancer.

Studies like this are crucial because they help scientists understand how new medicines work in humans. Even though it's an early stage, the information gathered from participants in this trial could one day lead to important new treatment options for people with various types of advanced cancers.

Key takeaways

This study is for adults (18+) with advanced solid tumours.
It's the first time the new medicine DT-9081 is being tested in people.
The main goals are to check the medicine's safety and how it works.
Regular hospital visits, tests, and scans will be part of participation.
You can stop taking part at any time without affecting your normal care.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and older. There's no upper age limit for taking part.

Participants must have a diagnosis of an advanced solid tumour. This means your cancer might have spread to other parts of your body (metastatic), it might have come back after previous treatment (recurrent), or doctors have decided it cannot be removed with surgery (unresectable).

Both men and women can take part in this study. Other specific medical conditions, past treatments, and general health will also be checked carefully by the study doctors to make sure it's safe for you to participate.

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?
Has your cancer been described as advanced (e.g., spread, returned, or not suitable for surgery)?
Are you able to travel to regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, DT-9081, as part of the study. You would have regular visits to the hospital or clinic for check-ups. These visits might include physical examinations, blood tests, and scans to monitor your health and how the medicine is affecting your cancer. The total duration of your participation, including how often you visit and for how long, would be explained in detail by the study team. They would also explain follow-up arrangements after you stop taking the study medicine.

Potential risks and benefits

Participating in a study like this might offer some potential benefits, such as access to a new treatment before it's widely available. It could also help us learn more about your cancer. However, as this is a new medicine, there are potential risks, including unknown side effects which could be mild or serious. The study team will explain all known and potential risks to you. You are free 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
France
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Unverified
Belgium

Common questions

What does a 'solid tumour' mean?

A solid tumour is a mass of abnormal tissue. It's different from blood cancers like leukaemia. Examples are breast cancer, lung cancer, or bowel cancer.

What does 'advanced cancer' mean in this study?

It means the cancer can't be removed by surgery, has come back after treatment, or has spread to other parts of the body.

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

Phase 1 means it's the very first time the new medicine is being tested in people. The main aim is to check if it's safe and what dose can be given.

What is DT-9081?

DT-9081 is a new medicine being studied. This trial is designed to understand how it works and if it's safe for people with advanced cancers.

Will I definitely get the new medicine?

Yes, if you meet all the study requirements and choose to participate, you would receive DT-9081.