A Phase I/II trial of UCB4594 in participants with advanced cancer.
Research type
Research Study
Full title
A Cancer Research UK Phase I/II trial to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of UCB4594 alone and in combination with anti-cancer treatments in participants with advanced malignancies.
IRAS ID
1008098
Contact name
David Gervais
Contact email
Sponsor organisation
Cancer Research UK
ISRCTN Number
ISRCTN26628699
Research summary
This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called HLA-G that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.
This clinical trial is split into two phases:
- Phase I is the ‘dose escalation’ phase. This is where small groups of participants receive UCB4594 at a certain dose level starting with a low dose level. After reviewing the results obtained at each dose level, it will be decided whether or how much to increase the dose for the next group of participants. This part of the study aims to find the best dose to give that does not cause too many side effects.
- Phase II is the ‘dose expansion’ phase. This starts when the dose escalation phase has worked out the best dose of UCB4594 to give. In this part of the trial UCB4594 will be given alone or in combination with other anti-cancer drugs. This will allow us to find out more about how the drug is working and whether UCB4594 affects cancer.The four main aims of the clinical trial are to find out:
- The best dose of UCB4594 that can be given safely to participants in the trial.
- What the side effects of UCB4594 are and how they can be managed.
- What happens to UCB4594 inside the body and how it affects cancer cells.
- Whether UCB4594 can cause cancer to shrink.REC name
North East - York Research Ethics Committee
REC reference
23/NE/0170
Date of REC Opinion
12 Dec 2023
REC opinion
Further Information Favourable Opinion