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

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation

This research study is looking at a new drug called JAB-21822 for adults who have advanced solid tumours with a particular genetic change known as the KRAS G12C mutation. This change can make cancers grow. The study has two main parts. In the first part (Phase 1), researchers are giving the drug for the first time to people to find the safest dose and understand any side effects. In the second part (Phase 2), they will look at whether the drug can shrink tumours or stop them from growing. They will also continue to monitor for safety. The aim is to see if JAB-21822 could be a helpful new treatment option for these types of cancer.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Jacobio Pharmaceuticals Co. Ltd.

Enrolment target

111

Start

18 Jul 2024

advanced solid tumors with KRAS G12C mutation

What is this study about?

This study aims to investigate a new medication, JAB-21822, for adults facing advanced solid tumours that have a specific genetic alteration called the KRAS G12C mutation. This mutation is found in certain types of cancer and can influence how they grow and respond to treatment. The study is divided into two main stages to carefully evaluate the new drug.

The first stage, called Phase 1, is focused on learning about the drug's safety. Since this is one of the first times JAB-21822 is being given to people, researchers will start with very small doses and gradually increase them. They will closely watch for any side effects and try to find the highest dose that is safe and tolerable for patients. They will also look at how the drug moves through the body.

The second stage, Phase 2, will involve more patients once a safe dose has been identified. In this part, the main goal is to see if the drug can make tumours smaller or stop them from growing. Researchers will measure the size of tumours over time to understand if JAB-21822 has an anti-cancer effect. They will also continue to monitor patient safety and how well the drug is tolerated.

Key takeaways

This study is testing a new drug, JAB-21822, for certain advanced solid cancers.
It's for people whose cancer has a specific genetic change called a KRAS G12C mutation.
The first part of the study focuses on finding a safe dose and understanding side effects.
The second part will look at whether the drug can shrink tumours.
Participation involves regular hospital visits for treatment and monitoring.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 and over, of any gender. To be considered, you must have advanced solid tumours that have tested positive for a specific genetic change called the KRAS G12C mutation. Your medical team will be able to confirm if your cancer has this particular mutation.

There might be other health conditions or medications that would prevent you from joining the study, to ensure your safety. The study doctors will carefully review your medical history to make sure it's appropriate for you to take part.

Quick self-check

Are you 18 years old or older?
Do you have a solid tumour that has spread or cannot be cured with surgery?
Has your cancer been tested and confirmed to have the KRAS G12C genetic mutation?
Are you able to travel to follow-up appointments regularly?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study drug, JAB-21822. You would have various check-ups, which include blood tests, heart rhythm tests (ECGs), and physical examinations to monitor your health and look for any side effects. Researchers will also regularly measure your tumour size using scans to see how the treatment is working. The exact number and frequency of visits, as well as the total length of your participation, will depend on which phase of the study you are in and how you respond to the treatment. There will also be follow-up appointments after you stop receiving the drug.

Potential risks and benefits

As with any new treatment, there are potential benefits and risks. The potential benefit is that JAB-21822 might help shrink your tumour or stop its growth, offering a new treatment option for your cancer. However, there is no guarantee it will work for everyone, and it might not work at all. Potential risks include experiencing side effects from the drug, which will be carefully monitored. Some side effects could be serious, and the study team will explain all known or expected side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Most cancers are solid tumours, like cancers of the lung, breast, or bowel.

What is the KRAS G12C mutation?

It's a specific change in the DNA of your cancer cells. This change can make the cancer grow and spread. Some newer drugs, like JAB-21822, are designed to target this specific mutation.

What does 'advanced' cancer mean in this study?

It means the cancer has spread beyond where it started or cannot be cured with surgery alone. This study focuses on new treatments for this stage of cancer.

Will I definitely get the new drug?

Yes, in this study, all participants will receive the investigational drug JAB-21822, either on its own or with other treatments.

What happens if the drug doesn't work for me?

If the drug isn't helping or if you experience significant side effects, the study doctors will stop the treatment. They will then discuss other available treatment options with you.