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

A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, Monotherapy or in Combination in Patients with Unresectable Locally Advanced or Metastatic Cancer

This research is a 'Phase 1/2' study, which means it's one of the first times this new medicine, called JK08, is being tested in people. It's for adults whose cancer has spread or is too advanced to be removed surgically. Researchers want to find the best and safest dose of JK08. They will test JK08 alone, and also in combination with two other cancer medicines, Keytruda and Lenvima. The main goal is to see how much of JK08 can be given safely without causing too many side effects, and to understand how it behaves in the body. They will also be looking for any shrinkage in the cancer. This study is an important step in developing new treatments for advanced cancer.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Salubris Biotherapeutics Inc.

Enrolment target

130

Start

06 May 2024

Unresectable Locally Advanced or Metastatic Cancer

What is this study about?

This clinical trial is looking into a new treatment called JK08. It's designed for adults who have cancer that has either spread to other parts of the body (metastatic) or is too advanced to be operated on and removed (unresectable locally advanced cancer). The study is considered 'Phase 1/2' because it's combining two early stages of research. In Phase 1, the main aim is to find the safest and most effective dose of the new medicine. In Phase 2, researchers look more closely at how well the medicine works against the cancer, while still monitoring for side effects.

The study will test JK08 in two ways: first, on its own, and then in combination with two other cancer medicines that are already used to treat various cancers – Keytruda and Lenvima. By combining these, researchers hope to see if JK08 works better when given with established treatments. The ultimate goal is to understand how JK08 affects the body, how much of it the body can safely handle, and whether it shows promising signs of fighting the cancer.

Finding new ways to treat advanced cancers is very important, especially for those that are difficult to treat with current options. Studies like this help us learn if new medicines are safe and effective, potentially opening doors for future treatments. Every step in this process, even these early phases, is crucial for advancing cancer care.

Key takeaways

This study is testing a new cancer medicine called JK08.
It's for adults with advanced cancer that can't be removed by surgery.
Researchers are looking for the safest dose of JK08, alone and with other medicines.
This is an early stage of research, focused on safety and initial effectiveness.
Participation involves regular clinic visits, tests, and careful monitoring.

Who may be eligible?

To join this study, you must be an adult, at least 18 years old. Both men and women can take part. The study is specifically for people whose cancer has either spread to other parts of their body or is too advanced to be removed by surgery.

There will be other specific health requirements that your doctor will check to make sure the study is safe and appropriate for you. For example, your general health, how well your organs are working, and any other medical conditions you have will be reviewed carefully.

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 or older?
Do you have cancer that has spread or can't be removed by surgery?
Are you able to attend regular clinic appointments?
Are you willing to undergo various tests including 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 will receive the new medicine, JK08, either by itself or with Keytruda or Lenvima, given as an infusion into your vein or as capsules you swallow. You'll have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. These visits will likely be frequent at the beginning of the study and may become less common over time. The study will also track how the medicine acts in your body. The exact number of visits, tests, and the total duration of your participation will be explained in detail by the study team, but generally, you will be followed closely throughout the treatment period and for some time afterwards.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available. However, there are also potential risks, including side effects from the study medication, which might be unknown. You could also experience discomfort from procedures like blood tests or scans. It's important to remember that the new treatment might not work for everyone, and it might not be better than standard treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Spain
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Unverified
Belgium

Common questions

What is 'unresectable locally advanced or metastatic cancer'?

This means your cancer has either spread to other parts of your body (metastatic) or is too advanced to be completely removed by an operation (unresectable locally advanced).

What is a 'Phase 1/2' study?

It's an early stage of clinical research. Phase 1 focuses on finding a safe dose, and Phase 2 looks at how well the new medicine works while still checking for side effects.

What are Keytruda and Lenvima?

These are existing cancer medicines that are sometimes given alongside new treatments to see if they work better together.

Why is this study looking at side effects?

A key part of early studies is to closely monitor for any side effects and understand how the body reacts to the new medicine to find the safest dose.

Will I know if JK08 is helping my cancer?

The study will use scans and other tests to monitor your cancer and your study doctor will discuss your results with you regularly.