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

A study of HFB200603 as a single agent and in combination with Tislelizumab in patients with advanced solid tumors

This study is looking into a new treatment, HFB200603, for adults with advanced solid cancers. It will be given either by itself or alongside another medicine called Tislelizumab. This is one of the very first times this new medicine is being given to people, known as a Phase 1 study. The main goal is to check if it's safe to use and to understand how the body reacts to it. Researchers will also be looking for any signs that the treatment might be helping with the cancer. People aged 18 and over, of any gender, who have advanced solid tumours will be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Hifibio Inc.

Enrolment target

Start

03 Jul 2023

Advanced Solid Tumors

What is this study about?

This research study is focused on a new medicine, which we'll call HFB200603, for people who have advanced solid tumours. "Advanced" means the cancer has grown or spread, and "solid tumours" are cancers that form a lump, unlike blood cancers. The study aims to see how this new medicine works both on its own and when combined with an existing treatment called Tislelizumab. Think of it like trying out a new recipe – first you taste the new ingredient by itself, and then you see how it blends with other flavours.

Because this is a very early-stage study (called Phase 1), the most important thing is to make sure the medicine is safe for people. Doctors will be carefully watching for any side effects and trying to find the right amount, or dose, of the medicine to give. They also want to understand how the body uses and gets rid of the medicine. While safety is the main focus, researchers will also be looking for any clues that the medicine might be helping to slow down or shrink the cancer.

Finding new ways to treat cancer is a long process, and studies like this are an essential first step. Each new treatment starts with these early tests to understand them better before they can be given to more people. This particular study is an important part of hopefully developing new and effective treatments for advanced solid tumours in the future.

Key takeaways

This study is testing a new cancer medicine (HFB200603) for the first time in people.
It's for adults aged 18 and over with advanced solid tumours.
The main goal is to check how safe the new medicine is and how the body reacts to it.
You might receive the new medicine by itself or with another treatment called Tislelizumab.
You will have regular hospital visits for treatments and health checks.
It's important to discuss any potential risks and benefits with your doctor.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. There is no upper age limit, so older adults can also take part. The study is open to both men and women.

The main condition for joining is that you have advanced solid tumours. This means your cancer has spread or cannot be removed by surgery. The doctors running the study will check your medical history and do some tests to make sure that the study is right for you, and that you meet all the necessary health requirements to take part safely.

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 advanced solid tumours?
Are you able to attend regular hospital appointments?
Are you willing to have medical tests like blood tests and scans?

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, HFB200603, either by itself or with Tislelizumab. This medicine might be given as a drip into your arm (infusion) or in another way, which the study team will explain.

You would have regular visits to the hospital or clinic to see the study doctors and nurses. During these visits, you'd have various tests, such as blood tests, scans, and physical examinations, to check your health, how the medicine is affecting your body, and whether your cancer is responding. The study team will explain how often these visits are and how long each one might take. You would be closely monitored throughout the study. The total duration of your involvement could vary, but the study team will provide a clear timeline for your treatment and follow-up appointments.

Potential risks and benefits

Taking part in any medical study has both possible benefits and risks. A potential benefit of joining this study is that you would receive a new medicine that is not yet widely available, which might help your cancer in some way, even though this is not guaranteed at such an early stage. However, like all medicines, HFB200603 and Tislelizumab can have side effects, which could range from mild to more serious. The study team will explain all known and possible side effects. It's very important to remember that joining a study is always your personal choice, and you are free to leave 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
Italy
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Unverified
Spain

Common questions

What does 'advanced solid tumours' mean?

It means you have a type of cancer that forms a lump, and it has either grown or spread to other parts of your body.

What is a 'Phase 1' study?

It's a very early stage of testing a new medicine in people. The main goal is to find out if it's safe and what effects it has on the body.

Will this medicine cure my cancer?

This study is too early to know if the medicine will cure cancer. The main aim is to check its safety and see how it works in the body.

Will I get the new medicine or a placebo (dummy treatment)?

Everyone in this study will receive the new medicine HFB200603, either on its own or with Tislelizumab. No one will receive a placebo.

How long will I be in the study?

The study team will tell you the expected length of your involvement, which includes treatment and regular follow-up visits.