A Phase I/IIa Trial of KJ-103 in Solid Cancers.
Research type
Research Study
Full title
A Cancer Research UK Phase I/IIa trial of KJ-103 Given as Monotherapy and Alongside Standard of Care Pembrolizumab in Participants with Advanced Solid Tumours.
IRAS ID
1012337
Contact name
Rashida Teladia
Contact email
Sponsor organisation
Cancer Research UK
ISRCTN Number
ISRCTN15819396
Research summary
Researchers are testing a new drug called KJ-103 in people with advanced solid tumours. This is the first time KJ-103 is being given to humans. The main aims of the trial are to find out:
The safest dose of KJ-103 to give to people;
How the drug behaves in the body;
Whether KJ-103 is effective on its own or when combined with another cancer treatment called pembrolizumab, which is already used as standard care for some cancers.
KJ-103 is a type of drug called a monoclonal antibody. It works by attaching to a protein called TROP2, which is found on the surface of certain cancer cells. KJ-103 also binds to a receptor on immune cells (called the Fc receptor, found on macrophages and natural killer cells). By doing this, KJ-103 acts like a bridge between cancer cells and immune cells, helping the immune system to recognise and destroy cancer cells. We hope this will make the immune cells in your body more active against cancer, but we cannot be sure if it will work at this stage.
The trial will take place at several hospitals and will include up to 133 participants. It is divided into different parts (called modules):
Module A: KJ-103 will be given on its own at different dose levels to small groups of participants to find the safest dose.
Module B: KJ-103 will be tested together with pembrolizumab. First, researchers will check the safety of the combination. Then, participants will be randomly assigned to receive either KJ-103 plus pembrolizumab or pembrolizumab alone.
Module C: Once the best dose is found, more participants will receive KJ-103 on its own to learn more about its effects.
KJ-103 is given by an intravenous (IV) infusion. Treatment is organised into cycles of 21 days. Participants may receive up to 12 cycles, and if they continue to benefit, they may receive up to 22 additional cycles.
This trial will help researchers understand if KJ-103 can be safely combined with pembrolizumab and whether it can help treat advanced cancers.REC name
North East - York Research Ethics Committee
REC reference
26/NE/0012
Date of REC Opinion
10 Mar 2026
REC opinion
Further Information Favourable Opinion