Actively Recruiting
A Phase I/II Trial of UCB4594 to Assess Safety, Pharmacokinetics, and Anti-cancer Effects in Participants With Advanced Solid Tumors
Led by Cancer Research UK · Updated on 2026-05-08
167
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
UCB Biopharma SRL
Collaborating Sponsor
AI-Summary
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 I/II 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.
CONDITIONS
Brief Title
A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and be able to follow study procedures
- Have histologically or cytologically confirmed advanced solid tumors with high HLA-G expression, refractory to standard treatments or without suitable conventional therapy
- Have measurable disease according to RECIST v1.1 criteria
- Have a life expectancy of at least 12 weeks
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have laboratory blood and biochemistry values within acceptable ranges
- Be aged 18 years or older at consent; participants aged 16-17 may be eligible for backfill cohorts after safety review
You will not qualify if you...
- Received radiotherapy (except palliative), chemotherapy, targeted therapy, immunotherapy, or other investigational drugs within 4 weeks prior to first study dose
- Have ongoing toxicity from previous treatments greater than CTCAE Grade 1 (except certain exceptions like alopecia or stable neuropathy)
- Have rapidly progressing or untreated brain metastases; treated brain metastases must be stable without recent seizures or steroid use
- Be pregnant, breastfeeding, or planning to breastfeed
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception or abstinence during and after the trial
- Male participants with partners of childbearing potential must use barrier contraception or abstain, and avoid sperm donation during and after the trial
- Not recovered from recent surgery
- Have serious uncontrolled infections or fever within 2 weeks before first dose
- Be positive for hepatitis B, hepatitis C, or HIV
- Have active or certain autoimmune diseases or history of organ transplant
- Be on high doses of corticosteroids or immunosuppressants (with some exceptions)
- Have hypersensitivity to UCB4594 ingredients
- Have history of severe infusion-related reactions to similar drugs
- Have prior treatment targeting HLA-G or related receptors
- Received live vaccines within 28 days before first dose
- Have conditions increasing risk of tumor flare or significant lung or heart disease
- Have bleeding disorders
- Participate in another interventional trial
- Have other active cancers unless disease-free for 3 or more years
- Any other condition judged by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive UCB4594 as an intravenous infusion once every 3 weeks for up to 18 cycles. This includes a dose escalation phase to find the best dose and a dose expansion phase to assess the drug's effects alone or in combination with other anti-cancer drugs.
Up to 18 visits every 3 weeks (in-person)
Trial Site Locations
Total: 4 locations
1
Guy's Hopsital
London, United Kingdom, SE1 9RT
Actively Recruiting
2
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
3
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
4
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Not Yet Recruiting
Research Team
F
Fiona Thistlethwaite, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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