Phase I study of MOv18 IgE.
Research type
Research Study
Full title
A Cancer Research UK Phase I study of MOv18 IgE, a first in class chimeric IgE antibody against folate receptor-α, in patients with advanced solid tumours.
IRAS ID
160295
Contact name
James Spicer
Contact email
Sponsor organisation
Cancer Research UK, Centre for Drug Development
Eudract number
2014-000070-19
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Therapeutic antibodies have significantly improved the prognosis of patients with a range of cancers. Currently available therapeutic antibodies belong to the IgG class. This study is looking at a new drug called MOv18 which belongs to a different class of antibody, the IgE class. IgE antibodies may trigger a more powerful immune response to tumour cells than these available IgG antibodies and so be more effective in treating certain types of cancer. This is the first time an IgE antibody therapy will be given to patients with cancer.
MOv18 antibodies are designed to recognise and attach to a particular protein called the folate receptor-alpha. Scientists have found more of this protein on the surface of certain cancer cells than on the surface of normal cells, most commonly ovarian cancer and to a lesser extent cancers of the kidney, pleura, endometrium, lung, breast, bladder, colon and pancreas. Once attached, the MOv18 IgE antibody should trigger the body’s own immune system to attack and kill the cancer cells.
The study will be conducted at two clinical trials units in the UK. Approximately 25 patients with advanced cancer which cannot be treated with surgery for which no alternative therapy is felt to be appropriate will be entered into this study. Patients' tumour tissue will be tested for the folate receptor protein to make sure their cancer is suitable for the treatment before they agree to take part. The study will follow a dose escalation design where small groups of patients are treated with a set dose, starting with a very low dose followed by increasing doses, to find a safe dose at which the drug has a good chance of effectively treating the cancer. Patients will receive a short course of treatment of six weekly doses given as an infusion in the hospital.Summary of Results
A summary of results is available at
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-mov18-ige-for-advanced-solid-tumours
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/0114
Date of REC Opinion
19 Jun 2015
REC opinion
Further Information Favourable Opinion