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

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

This study is looking at a new treatment called HFB200301 for adults who have advanced solid tumours. This means cancers that have spread from their original location. It's an early-stage study, which means it's one of the first times this new medicine is being given to people. Researchers want to find out if HFB200301 is safe and what dose can be given without causing too many side effects. They will also see how it works on its own and when given together with another cancer drug called Tislelizumab. The main goal is to understand how the new medicine behaves in the body and if it shows any signs of helping with cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Hifibio Inc.

Enrolment target

188

Start

22 Apr 2024

Advanced Solid Tumors

What is this study about?

This study is about a new treatment called HFB200301 for people who have advanced solid tumours. "Solid tumours" are basically lumps of cancer cells, like those found in breast, lung, or bowel cancer, rather than blood cancers. "Advanced" means the cancer has grown or spread beyond where it started. Learning about new treatments for advanced cancers is really important because it could lead to new ways to help patients in the future.

This is a 'Phase I' study, which is the very first step in testing a new medicine in people. The main aim at this stage is to make sure the treatment is safe and to find the right dose. Think of it like taking a new car for its first test drive – you want to make sure all the essential parts work correctly before you try it out on a long journey. The study will also look at how HFB200301 works in the body and if it has any effects on the cancer.

Researchers will be giving HFB200301 on its own to some patients and also combined with an existing cancer treatment called Tislelizumab to others. By doing this, they can see if the new medicine works better with other treatments or if it's effective on its own. The information gathered from this study will be used to decide if HFB200301 should be tested further in larger studies, moving us closer to potentially new and effective cancer treatments.

Key takeaways

This study is testing a new cancer medicine, HFB200301.
It's for adults with advanced solid tumours.
The main aim is to check the medicine's safety and find the right dose.
It's an early-stage study (Phase I).
Participation involves regular hospital visits for health checks.
You can stop taking part at any time.

Who may be eligible?

To be able to join this study, you need to be an adult, at least 18 years old.

This study is for people who have advanced solid tumours. Doctors will check your medical history and test results to see if your cancer fits the study's requirements.

Because this is an early study of a new medicine, there will be other specific health checks and tests to make sure it's safe for you to take part. This helps protect your health and makes sure the results of the study are clear.

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?
Have you been diagnosed with an advanced solid tumour?
Are you able to travel to the study site for regular appointments?
Are you willing to follow a specific treatment and testing schedule?
Are you open to trying a potential new treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, HFB200301, and possibly Tislelizumab, according to a schedule set by the study doctors. You would have regular visits to the hospital or clinic for blood tests, physical examinations, and other checks to see how you are doing and how the medicine is working. This is important to monitor your health and any side effects.

These visits might be quite frequent at the beginning of the study. The exact number of visits, how long each visit lasts, and the total duration you might be involved in the study will be explained in detail by the study team. You would also have follow-up appointments after you stop taking the medicine to make sure you remain well.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might have access to a new treatment before it's widely available. The information gained from this study could also help others with similar conditions in the future. However, we don't know for sure if HFB200301 will help your cancer, as it's an early-stage drug. There's a chance you might experience side effects from the new medicine, which could be mild or more serious. The study team will explain all known or expected risks. You always have the right to withdraw from 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
Spain

Common questions

What does 'advanced solid tumours' mean?

It means the cancer started as a solid lump and has grown or spread from where it first appeared in your body.

What is a 'Phase I' study?

It's the first stage of testing a new medicine in people, mainly to check if it's safe and to find the right dose.

Will this new medicine cure my cancer?

It's too early to say. The main goal of this study is to find out if the medicine is safe and how it works, not primarily to cure cancer.

Will I have to travel a lot for the study?

Yes, you would need to attend regular appointments at the study site, which could involve frequent visits, especially at the start.

Can I stop taking part if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.