- A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer — Recruiting • Phase I • Oncology • NCT06380816.
- Drug being tested: UCB4594 is a novel monoclonal antibody undergoing first-in-human Phase I/II evaluation, designed to target a specific protein implicated in advanced cancer pathogenesis.
- Patient eligibility: The trial enrolls adults with advanced/metastatic cancer who have exhausted standard treatment options or for whom no standard therapy exists, typically requiring adequate organ function and performance status.
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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…
- : 1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up
- Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the participant. Module A (dose escalation): Tumour types which have shown high levels of human HLA-G expression (as reported in the literature): head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, renal cell cancer (clear cell only), oesophago-gastric cancer (excluding gastrointestinal stromal tumour), cervical cancer, ovarian cancer, pancreatic cancer. N.B. Participants with small cell type cancers on histology/cytology are excluded. Pre-treatment biopsies are mandatory for all participants. Paired biopsies will be mandatory for participants from doses of 30 mg and higher. Participants must have disease amenable to biopsy (excluding bone metastases) as deemed safe by the Investigator 3. Measurable disease, according to RECIST v1.1 4. Life expectancy of at least 12 weeks 5. Eastern Cooperative Oncology Group performance status of 0 or 1 6. Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.