Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)

This research study is for adults with a type of stomach and bowel cancer called Gastrointestinal Stromal Tumours (GIST). It's an early-stage study (Phase 1/2) that aims to find out more about a new medicine called THE-630, which is taken by mouth. The study has two main parts. The first part (Phase 1) is about checking how safe different doses of THE-630 are and finding the best dose to use. The second part (Phase 2) will then use this dose to see if the medicine can make tumours smaller. Researchers will also be looking at how the medicine works in the body and if it has any effects on the cancer over time. This is a crucial step in understanding if THE-630 could be a helpful new treatment for GIST.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Theseus Pharmaceuticals Inc.

Enrolment target

Start

02 Jun 2023

Gastrointestinal Stromal Tumors (GIST)

What is this study about?

This study is looking into a new medicine called THE-630, which is designed to treat a type of cancer known as Gastrointestinal Stromal Tumours (GIST). GIST is a relatively rare cancer that usually starts in the digestive system, most often in the stomach or small intestine. The medicine, THE-630, is a 'KIT inhibitor,' which means it targets specific faulty signals within cancer cells that cause them to grow.

The study has two main stages, called Phase 1 and Phase 2. In Phase 1, the main goal is to understand how safe THE-630 is when taken by people and to find the highest dose that can be given without causing too many side effects. This involves starting with a small dose and gradually increasing it while closely monitoring participants for any reactions. Researchers are also interested in how the body processes the medicine – how it's absorbed, distributed, broken down, and removed. In Phase 2, once a safe and effective dose is found, the study will focus on seeing if THE-630 can shrink tumours or stop them from growing in people with GIST.

Ultimately, the aim of this research is to see if THE-630 could become a new treatment option for people living with advanced GIST. By carefully studying its safety and how well it works, scientists hope to gather enough information to develop this medicine further. It's an important step in exploring new ways to fight this type of cancer.

Key takeaways

This study is testing a new oral medicine, THE-630, for advanced GIST.
It's a Phase 1/2 study, meaning it checks safety, dosage, and early effectiveness.
Participants must be 18 or older with advanced GIST.
You'll have regular hospital visits, blood tests, and scans.
The goal is to see if THE-630 can shrink tumours and improve outcomes.
Your doctors will explain all known benefits and risks before you decide.

Who may be eligible?

To join this study, you must be an adult, aged 18 or older.

You would need to have been diagnosed with advanced Gastrointestinal Stromal Tumours (GIST).

There will be other important medical requirements that only your doctor can check. These will likely include things like your overall health, other medicines you are taking, and how your cancer has responded to previous treatments.

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 advanced Gastrointestinal Stromal Tumours (GIST)?
Are you willing and able to attend regular hospital appointments and tests?
Are you able to take medicines by mouth?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, THE-630, which is taken by mouth. You will be monitored very closely, especially in the early stages as the researchers work to find the right dose. This will involve regular visits to the hospital or clinic.

During these visits, you'll have various tests, which may include blood tests to check how the medicine is affecting your body and how it's moving through your system. You'll also have scans (like CT scans or MRI scans) to see if the medicine is having an effect on your tumours. You will also be asked about any side effects you might be experiencing.

The total duration of your participation in the study will depend on how you respond to the treatment and the stage of the study you are in. There will also be a follow-up period after you stop taking the main study medicine to monitor your health.

Potential risks and benefits

Taking part in a clinical trial like this may offer potential benefits, such as access to a new medicine that is not yet widely available, and close medical monitoring. However, there are also potential risks, as THE-630 is an experimental medicine and its full effects are not yet known. Like all medicines, it may cause side effects, some of which could be serious. You will be fully informed of all known and potential risks before you decide to join. Remember, your participation is completely voluntary, 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
France

Common questions

What are GISTs?

GISTs are a type of cancer that starts in the digestive system, most often the stomach or small intestine.

What does a 'Phase 1/2' study mean?

It means the study is in its early stages. Phase 1 focuses on safety and finding the right dose, while Phase 2 looks at whether the medicine works to shrink tumours or stop them growing.

What is THE-630?

THE-630 is a new medicine being tested. It's a type of drug called a 'KIT inhibitor,' which aims to target specific cancer growth signals.

Will I definitely get the medicine?

If you join the study, you will receive THE-630. There isn't a placebo group in this type of study.

What if I experience side effects?

You will be closely monitored, and any side effects will be carefully managed by the study team. You should report any new or worsening symptoms straight away.