Phase III Study of UCB4594, a Monoclonal Antibody Targeting HLA-G, Alone and With Other Cancer Treatments in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating UCB4594, a monoclonal antibody designed to target human leucocyte antigen G HLA-G, a protein found in high levels on some cancer cells. This Phase III clinical trial aims to find the safest and most effective dose of UCB4594, understand its side effects and how to manage them, study how the drug behaves in the body, and assess whether it can shrink cancer. The trial focuses on participants with advanced solid tumors that express HLA-G and are resistant to conventional treatments. The trial is divided into two phases. Phase I Module A involves dose escalation where small groups receive increasing doses of UCB4594 given as an intravenous infusion every three weeks for up to 18 cycles about one year. Phase II includes dose expansion with UCB4594 given alone Module B or combined with other anti-cancer drugs Module C to further study its effects. Module C details will be added once specific cancers and combination treatments are defined. Participants will undergo regular assessments including biopsies and radiological scans to measure tumor response and drug levels in the body. Researchers will monitor safety by tracking adverse events from consent through up to 12 months after treatment. The study includes detailed follow-up for up to 13 months to evaluate how the drug is processed and how it impacts cancer. The total participation period may last approximately one year or more depending on treatment cycles and assessments.

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