Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Study of HMPL-306 in Locally Advanced Solid Tumors with IDH mutations

This research study is testing a new drug called HMPL-306. It's for adults who have advanced solid tumours, which means cancer that has grown or spread, and specifically when these cancers have a particular change in their genes, known as an IDH mutation. This includes cancers like cholangiocarcinoma (a type of bile duct cancer), chondrosarcoma (a type of bone cancer), and low-grade glioma (a type of brain tumour), as well as other solid tumours with this specific gene change. This is a very early-stage study (Phase 1), which means researchers are mainly trying to find out if the drug is safe, what dose works best, and how the body handles it, rather than if it cures the cancer. It's a first step in testing HMPL-306 in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Hutchmed Ltd.

Enrolment target

Start

04 Sep 2024

What is this study about?

This study is about a new investigational medicine called HMPL-306. An investigational medicine is one that is still being tested and hasn't been approved for general use. The study focuses on people who have certain types of advanced cancer. These cancers are special because they all have a particular gene change, or 'mutation', called an IDH mutation. This mutation can cause cancer cells to grow differently.

The types of cancer being looked at include advanced conditions like cholangiocarcinoma (a cancer that starts in the bile ducts), a type of bone cancer called skeletal chondrosarcoma, and a type of brain tumour known as low-grade glioma. It also includes any other solid tumour that has this specific IDH gene fault. 'Solid tumours' refer to cancers that form a lump or mass, rather than liquid cancers like leukaemia.

This is a 'Phase 1' study. In medicine research, studies are done in phases. Phase 1 is the very first stage where a new medicine is given to people. The main goals at this stage are to check if the medicine is safe, to find the right dose, and to see how the body reacts to it. It's not about proving the medicine cures cancer, but rather about gathering important information before moving on to larger studies.

Key takeaways

This is an early-stage study (Phase 1) of a new cancer medicine.
It's for specific advanced solid tumours with an 'IDH mutation'.
The main aim is to check the medicine's safety and find the right dose.
Participation involves receiving the medicine and close medical monitoring.
It could offer a new treatment option, but risks and benefits are still being understood.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages can potentially take part. Both men and women are welcome to participate.

The most important requirement is that you must have an advanced solid tumour, which means your cancer has spread or is difficult to treat in its current location. Crucially, your cancer must also have a specific genetic change, known as an IDH mutation. This is a key part of the study, as the new medicine is designed to target this particular genetic fault.

The study is looking for people with certain types of cancer, including cholangiocarcinoma (a type of bile duct cancer), skeletal chondrosarcoma (a type of bone cancer), or low-grade glioma (a type of brain tumour) that have this IDH mutation. If you have any other solid tumour with an IDH mutation, you might also be considered.

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 an advanced solid tumour?
Has your cancer been tested and confirmed to have an 'IDH mutation'?
Is your cancer one of the types mentioned (cholangiocarcinoma, chondrosarcoma, low-grade glioma) or another solid tumour with an IDH mutation?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to a clinic. During these visits, the study team would monitor your health closely. This would include physical examinations, blood tests, and scans to see how your body is responding to the new medicine. You would receive the study medicine, HMPL-306, as directed by the research team.

Because this is an early-stage study, the exact number of visits, tests, and the total duration aren't specified but are generally more frequent with earlier phase studies. You would likely be monitored throughout your treatment and possibly for a period after your treatment ends to ensure your safety and to collect all necessary information. The study team would explain the full schedule and what's expected of you, including any follow-up appointments.

Potential risks and benefits

Because this is an early-stage study, the full benefits and risks of HMPL-306 are not yet known. A potential benefit could be that the new medicine might help control your cancer, or slow its growth, especially since it targets a specific change in your cancer. However, as with any new drug, there’s a risk of side effects, which could range from mild to serious. The study team will carefully monitor you for any side effects and explain all known risks. Remember, participation is 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 (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 is an IDH mutation?

An IDH mutation is a change in a specific gene within your cancer cells. Researchers believe this change contributes to cancer growth, and the study drug is designed to target it.

What does 'Phase 1' mean?

Phase 1 means this is the first time the new drug, HMPL-306, is being tested in people. The main goals are to check if it's safe and to find the best dose, not yet to prove it cures cancer.

Will I get the actual study drug or a placebo?

In Phase 1 studies like this, participants usually receive the active study drug. Placebos are more common in later-stage studies.

How long will I need to be in the study?

The exact duration isn’t specified, but Phase 1 studies involve regular monitoring during treatment and usually follow-up after, which could last several months or longer. The study team will provide more details.

What if the drug doesn't work for me?

There's no guarantee the drug will be effective. The study team will monitor your progress, and if the drug isn't helping or if you have serious side effects, they will discuss your options with you.