Actively Recruiting
A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer
Led by Cancer Research UK · Updated on 2026-05-08
167
Participants Needed
4
Research Sites
277 weeks
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
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.
CONDITIONS
Official Title
A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and can cooperate with treatment and follow-up
- Have advanced solid tumors confirmed by biopsy that are resistant to standard treatments or no suitable treatment is available
- Tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, clear cell renal cell cancer, esophago-gastric cancer (excluding gastrointestinal stromal tumor), cervical cancer, ovarian cancer, pancreatic cancer
- Must have measurable disease by RECIST v1.1 criteria
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Blood and biochemistry tests within defined ranges to confirm eligibility
- Age 18 years or older at consent (participants aged 16-17 may be eligible after safety data review)
- Must have disease suitable for biopsy (excluding bone metastases) and able to undergo pre-treatment biopsies
You will not qualify if you...
- Received chemotherapy, radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), targeted therapy, immunotherapy, or other investigational drugs within 4 weeks before first dose
- Ongoing side effects from previous treatments above Grade 1 (except alopecia, stable Grade 2 peripheral neuropathy, or hormone-replacement therapy-managed endocrine disorders)
- Rapidly progressing or untreated brain metastases; previously treated brain metastases allowed if stable
- Pregnant or breastfeeding women
- Women of childbearing potential without negative pregnancy test and effective contraception or abstinence
- Male patients without barrier contraception or sexual abstinence; males with pregnant partners must use barrier contraception
- Recent surgery from which patient has not recovered
- Serious or uncontrolled non-cancer medical conditions including infections with fever above 38°C
- Positive for hepatitis B, hepatitis C, or HIV
- Active or certain histories of autoimmune diseases requiring systemic steroids or immunosuppressants; certain stable autoimmune conditions allowed
- Use of high-dose corticosteroids or immunosuppressants (some exceptions apply)
- Allergy to ingredients in UCB4594
- History of severe infusion reactions to similar drugs
- Previous treatment targeting HLA-G, ILT2, or ILT4
- Live attenuated vaccine within 28 days before first dose
- Risk of tumor flare causing airway obstruction
- Significant active lung disease including lymphangitis carcinomatosa, interstitial lung disease, pulmonary fibrosis, or pulmonary inflammatory disease
- Bleeding disorders
- Significant heart disease including heart failure, recent heart attack, unstable angina, certain arrhythmias, or severe valvular disease
- Participation in another interventional trial
- Other current cancers except those disease-free for 3 or more years
- Any condition making participation unsafe or unsuitable in investigator's opinion
AI-Screening
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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
CONTACT
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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