Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors

This is a very early study, called a Phase 1 trial, for adults who have solid cancers that are advanced or have spread to other parts of the body. The main goal is to learn more about a new medicine called Subasumstat, specifically how it's handled by the body. Researchers want to see how much of the medicine enters the bloodstream, how long it stays there, and how the body changes and gets rid of it. This information is important for understanding if the medicine could be helpful in treating cancer and how it might work in people. Participants will receive a special version of the medicine that can be traced to help scientists understand its journey through the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

21 Sep 2023

Advanced or Metastatic Solid Tumours

What is this study about?

This study is an early step in testing a new medicine called Subasumstat. When new medicines are developed, they go through different stages of testing. This is a "Phase 1" study, which means it's one of the first times this medicine is being given to people. The main focus at this stage isn't to see if the medicine treats cancer, but rather to understand how it behaves inside the human body. This includes looking at things like:

How the medicine is absorbed into the bloodstream. How it spreads around the body. How the body breaks down the medicine. How the body gets rid of it. To do this, participants will receive a special version of Subasumstat that has a tiny, harmless tracer (a 14C label) attached. This tracer allows researchers to carefully follow the medicine's journey through the body and measure exactly what happens to it.

The information gathered from this study is really important. It helps scientists understand if the medicine is safe enough to test further and how it might be given in future studies. It also gives them clues about how the medicine might work, which is vital for developing effective cancer treatments. By participating, you would be contributing valuable information that could help many people in the future.

Key takeaways

This is an early study for adults with advanced/spreading solid cancers.
The focus is on how a new medicine, Subasumstat, works in the body.
It helps scientists understand safety and dosage for future research.
You would receive a traceable version of the medicine.
Participation involves clinic visits and sample collection.
Your well-being and ability to withdraw are always respected.

Who may be eligible?

This study is looking for adult men and women, aged 18 and over. Participants must have solid cancers that are considered advanced or have spread to other parts of the body.

To join, you would need to meet certain health requirements. This ensures the study is as safe as possible for you. The medical team will check blood tests and other health information to make sure this study is suitable. You would not be able to join if you have certain other medical conditions or if you are already receiving certain treatments that might interfere with the study medicine.

It's important to have a detailed discussion with your doctor to understand all the specific requirements and to see if this study is a good fit for your individual situation. They will have all the detailed information to help you decide.

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 is advanced or has spread?
Are you able to attend regular clinic visits?
Are you willing to have blood and urine samples taken as required?
Are you generally feeling well enough to take part in a study?
Have you discussed clinical trials with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, Subasumstat. Because this study is about understanding how the body handles the medicine, there would be several visits to the clinic. These visits would involve providing blood and urine samples at specific times after taking the medicine. This helps researchers track the medicine's journey through your body. You might also have other tests, like scans, to monitor your health.

The study would involve careful monitoring by the medical team. The total duration of your participation and the exact number of visits would be explained in detail by the study team. They will also tell you if you need to stay in the clinic for any periods during the study. There would also be follow-up appointments after you stop taking the medicine to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and potential risks. You might not directly benefit from this study, as it primarily aims to gather information about a new medicine. However, the information learned could help others in the future. As with any new medicine, there's a chance of side effects, which the study team will explain based on what they already know. Your safety and well-being are the top priority. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Hungary

Common questions

What does 'advanced or metastatic solid tumours' mean?

This refers to cancers that have grown or spread from where they first started to other parts of your body. 'Solid tumours' means it's a cancer that forms a lump or mass, not a blood cancer like leukaemia.

What is a 'Phase 1' study?

It's the first stage of testing a new medicine in people. The main goal is to understand if it's safe and how your body handles it, rather than directly treating your cancer yet.

What does 'mass balance, pharmacokinetics, and metabolism' mean?

It's a scientific way of saying researchers want to understand exactly how much of the medicine enters your body, how it travels, how your body changes it, and how it leaves your body.

Will I get '14C' inside me?

Yes, you will receive a version of the medicine with a very small, harmless, and traceable amount of carbon-14. This is a common and safe way for scientists to track the medicine's journey through your body.

Will this medicine cure my cancer?

The main goal of this very early study is not to cure cancer, but to gather important information about a new medicine. We hope this information will lead to better treatments in the future.