We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Fiona
Thistlethwaite
+44 (0)161 9187672
fiona.thistlethwaite@nhs.net
Mrs
Karen
Dyer
Dr
David
Gervais
Advanced solid tumours
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other investigational medicinal products (IMPs) during the previous 4 weeks or 5 half-lives (whichever is shorter) before the first dose of IMP 2. Ongoing toxicity of previous treatments >CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement therapy (HRT)-managed endocrine disorders) 3. Patients with rapidly progressing / symptomatically deteriorating brain/leptomeningeal metastases/untreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't had a seizure or a clinically significant change in neurological status or required steroids in the last 2 weeks4. Pregnant or breastfeeding female patients (or planning to breastfeed)5. Women of childbearing potential. However, those not already pregnant or breastfeeding (or discontinue breastfeeding) and meet the following are eligible:5.1. Have a negative serum pregnancy test within 7 days before enrolment and either: 5.2.1. Agree to a form of highly effective contraception plus a barrier method, or5.2.2. Agree to sexual abstinenceEffective from the negative pregnancy test, throughout the trial and for 10 months after the last dose of UCB4594.6. Male patients with partners of childbearing potential. However, patients who meet the following are eligible: 6.1. Agree to a barrier method of contraception or sexual abstinence6.2. Males with pregnant or breastfeeding partners must use barrier method contraception to prevent exposure of the foetus or neonate6.3. Non-vasectomised males must also ensure any partner of childbearing potential uses highly effective contraception or agrees to sexual abstinenceEffective from the date of the first dose of UCB4594, throughout the trial and for 5 months after the last dose of UCB4594N.B. Males must refrain from donating sperm for the same period7. Surgery from which the patient has not yet recovered8. High medical risk because of non-malignant systemic disease, including serious or uncontrolled infection (requiring IV antibiotics) or unexplained fever >38°C within 2 weeks prior to the first dose of UCB45949. Known to be serologically positive for hepatitis B virus, hepatitis C virus or human immunodeficiency virus10. Active or suspected autoimmune disease, or any history of autoimmune condition that required systemic corticosteroids or immunosuppressive agents. Patients who have ever had a transplant are excluded. This does not apply to patients with: vitiligo, alopecia, or type I diabetes mellitus, psoriasis not requiring chronic systemic immunosuppressive treatment within the past 2 years, stable autoimmune-mediated hypothyroidism on HRT, and Raynaud’s syndrome11. Are being treated with escalating or supraphysiologic doses of corticosteroids or immunosuppressive agents. Participants with immunotherapy-related hypophysitis adequately treated with physiologic doses of steroids are not excluded. Use of topical, ophthalmic, inhaled, intermittent steroid injections, and intranasal corticosteroids are permitted12. Hypersensitivity to the ingredients/excipients (including polysorbate 80) in UCB459413. History of significant toxicities from treatment of immune checkpoint inhibitors (CPIs) that necessitated permanent discontinuation (Patients who started on combination CPI [e.g., ipilimumab/nivolumab] and had toxicity requiring discontinuation of one CPI [e.g., continued with nivolumab single agent] are not excluded)14. History of Grade ≥3 infusion-related reaction to monoclonal antibodies or similar drugs15. Prior treatment with HLA-G, immunoglobulin-like transcript (ILT)2 or ILT4-targeting drug16. Live, attenuated vaccine within 28 days prior to the first dose of IMP17. Increased risk due to tumour flare (e.g., an initial increase in tumour size that may lead to obstruction of airways, etc)18. Significant active pulmonary disease or condition at screening, including:18.1. Lymphangitis carcinomatosa18.2. History of interstitial lung disease or pulmonary fibrosis18.3. History of pulmonary inflammatory disease19. Evidence of bleeding diathesis20. Significant cardiovascular disease, defined as a history of: congestive heart failure requiring therapy or left ventricular ejection fraction <40%, unstable angina pectoris or myocardial infarction within 6 months prior to entry, or current poorly controlled angina (symptoms weekly or more), clinically significant cardiac arrhythmia within 6 months prior to entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block permitted), or myocarditis. Presence of symptomatic or severe valvular heart disease. Baseline QT interval corrected by Fridericia>450 msec for males and >470 msec for females on triplicate electrocardiogram is ineligible21. Participant in or plans to join another interventional trial22. Other current malignancies. Cancer survivors who have undergone potentially curative therapy for prior malignancy with no evidence of disease for 3+ years are eligible23. Any other condition that, in the Investigator’s opinion, means the trial is not in the patient’s best interest
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
David
Gervais
Prof
Fiona
Thistlethwaite
+44 (0)161 9187672
fiona.thistlethwaite@nhs.net
Mrs
Karen
Dyer
The study is sponsored by Cancer Research UK and funded by Cancer Research UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 58100
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
