Not yet recruitingPhase I/IIInterventional

A Phase I/IIa trial of KJ-103 in solid cancers

This research is looking at a new drug, KJ-103, for people with advanced solid cancers such as head and neck, bladder, breast, and lung cancers. This is the first time KJ-103 has been used in humans. The main goals are to figure out the safest dose of KJ-103, understand how it works in the body, and see if it can help treat cancer. It will be tested alone and also with an existing cancer treatment called pembrolizumab. KJ-103 works by helping your immune system find and destroy cancer cells. The study will also assess if this new drug can be safely combined with pembrolizumab and if it is effective against advanced cancers.

At a glance

Status

Not yet recruiting

Phase

Phase I/II

Sponsor

Cancer Research UK

Enrolment target

133

Start

16 Jun 2026

Estimated completion

27 Feb 2029

Advanced solid tumour types which are known to have a high frequency of TROP2 positivity (e.g., head and neck squamous cell carcinoma [HNSCC], urothelial, breast cancer, non-small cell lung cancer [NSCLC])

What is this study about?

Researchers are currently running an important study to learn more about a new drug called KJ-103. This drug is being tested as a potential treatment for advanced solid cancers, which are cancers that have spread or come back. This is an early-stage study, meaning it's the very first time KJ-103 is being given to people. This is a vital step in developing new medicines, as it helps scientists understand how the drug works in the human body.

The main aims of this study are quite simple: first, the researchers want to find the safest amount, or dose, of KJ-103 to give to patients. Second, they want to understand how the drug behaves once it's in the body. And third, they are looking to see if KJ-103 can help treat cancer, either when given on its own, or when combined with another treatment called pembrolizumab, which is already used for some cancers.

KJ-103 is designed in a clever way: it's a type of drug called a 'monoclonal antibody'. Think of it like a specific key that only unlocks certain doors. In this case, KJ-103 is designed to attach to a protein called TROP2, which is often found on the surface of cancer cells. It also connects with certain cells in your immune system. By doing this, KJ-103 acts like a bridge, bringing your immune cells closer to the cancer cells to help your body fight them more effectively. The hope is that this will make your immune system more active against the cancer, but at this early stage, we can't be sure if it will work.

Key takeaways

This is a first-in-human study of a new drug called KJ-103 for advanced solid cancers.
The main goals are to find a safe dose and see how KJ-103 affects cancer, alone or with pembrolizumab.
KJ-103 aims to help your immune system recognise and destroy cancer cells.
Participation involves different stages of treatment with KJ-103, sometimes with pembrolizumab.
Your safety is a top priority, and you will be closely monitored as this is a new drug.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 16 years old. You must have a solid cancer that is advanced, meaning it has either come back after treatment or spread to other parts of your body. Doctors will also need to be able to measure your cancer to see if the treatment is having an effect.

Before you can take part, your medical team will do some checks to make sure you are well enough. This includes testing your blood and checking your general health. You also need to be able to give a tumour sample, which helps researchers understand more about your cancer and how the drug might work.

It's important to remember that not everyone who wants to join a study will be able to. The research team will carefully review your health information to make sure the study is right and safe for you.

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 16 years old or over?
Do you have an advanced solid cancer that doctors can measure?
Are you generally well enough to take part in a study?
Are you able and willing to provide a fresh tumour sample?
Have your blood tests shown your organs are working well enough?
Are you willing to provide written consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve different stages. In the first stage (Module A), small groups of people will receive KJ-103 on its own, with different doses being tested to find the safest one. In another stage (Module B), KJ-103 will be given alongside pembrolizumab. First, they'll check if this combination is safe, and then some participants will get both drugs, while others will just get pembrolizumab.

Once the safest and most effective dose is found, more people will receive KJ-103 on its own (Module C) to gather more information. KJ-103 is given directly into a vein through a drip (this is called an intravenous or IV infusion). Your treatment will be organised into cycles, with each cycle lasting 21 days. You could receive up to 12 cycles, and if the treatment is helping you, you might be able to continue for an additional 22 cycles.

Potential risks and benefits

Since KJ-103 is a new drug, it has never been given to people before this study. This means we don't know the exact benefits or side effects it might have in humans yet. Scientists have learned about potential risks and benefits from lab tests and from studying similar drugs. The research team will monitor you very closely throughout the study to quickly identify any effects of KJ-103, and the study has been carefully designed with your safety as a top priority. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Clatterbridge Cancer Centre
Approximate
Wirral, England
The Christie NHS Foundation Trust
City only
Manchester, England
Barts Health NHS Trust
City only
London, England
Royal Free Hospital
Approximate
London, England

Common questions

What type of cancers are being studied?

This study is for advanced solid cancers, including head and neck, bladder, breast, and a type of lung cancer (non-small cell lung cancer).

What is KJ-103?

KJ-103 is a new investigational drug that works by helping your immune system target and fight cancer cells.

Will I get both KJ-103 and pembrolizumab?

In some parts of the study, you might receive KJ-103 alone, and in other parts, it might be combined with pembrolizumab, or you might receive pembrolizumab alone.

How long will the treatment last?

Treatment is given in 21-day cycles. You could have up to 12 cycles, and potentially another 22 cycles if the treatment is helping you.

Where is the study taking place and who is running it?

The study is run by Cancer Research UK and is funded by Cancer Research UK and Kisoji Biotechnology Inc.

How to find out more

Rashida Teladia

Rashida.Teladia@cancer.org.uk +44 (0)300 123 1022 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.