RecruitingPhase 1Phase 2NCT06380816

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

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


Sponsor

Cancer Research UK

Enrollment

167 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

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 human leucocyte antigen G (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. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial (Phase I/II) tests a new immunotherapy drug called UCB4594 in patients with advanced solid tumors. UCB4594 targets a protein called HLA-G found on certain cancer cells. The study will evaluate safety and find the right dose. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor that no longer responds to standard treatments (including certain head and neck cancers, lung cancer, colorectal cancer, triple-negative breast cancer, kidney cancer, esophageal/stomach cancer, or cervical cancer) - You are willing and able to participate and consent **You may NOT be eligible if...** - You have already exhausted all relevant standard treatment options (specific criteria apply) - Your overall health is too poor for the treatment - You have other conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUCB4594

Participants will receive UCB4594 as an intravenous infusion once every 3 weeks for up to 18 cycles, with each cycle lasting 21 days (\~1 year).


Locations(2)

The Christie NHS Foundation Trust

Manchester, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

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NCT06380816


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