Phase I Study of MOv18 IgE, a First in Class Chimeric IgE Antibody in Patients With Advanced Solid Tumours
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|ClinicalTrials.gov Identifier: NCT02546921|
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Cancers||Drug: MOv18 IgE||Phase 1|
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 IgE 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.
Patients will be selected based on the presence of folate receptor protein on their tumour in a previous biopsy. The study is the first study of this new antibody treatment to be given to humans and will focus primarily on the assessment of safety confirming the findings of preclinical studies that exposure to MOv18 IgE will not trigger anaphylaxis. This is in addition to extensive PK, biodistribution of the antibody and immunological response. The study will follow a dose escalation design where small groups of patients are treated at a set dose, starting with a very low dose followed by exponential 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. The majority of patients treated at the higher dose levels will be asked to provide a pre and post treatment biopsy to explore the effect of the treatment on the tumour.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||A Cancer Research UK Phase I Study of MOv18 IgE, a First in Class Chimeric IgE Antibody Against Folate Receptor-alpha, in Patients With Advanced Solid Tumours|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
- Drug: MOv18 IgE
The allocated dose of MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for six weeks.
- Reported safety information (adverse events graded for severity using the NCI CTCAE version 4.02) [ Time Frame: Safety data will be collected from the time of informed consent until 56 days after the last dose of MOv18 IgE. ]Reported safety information in the form of adverse events graded for severity using the NCI CTCAE version 4.02 and which will be assessed by the reporting study doctors for a causal relationship to MOv18. Adverse events related to infusion with MOv18 will be categorised as being either due to IgE mediated mast cell degranulation i.e. anaphylaxis or as cytokine release syndrome.
- Antitumour activity measured according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 [ Time Frame: Radiological disease assessment at screening/baseline and every 6 weeks to end of treatment ]
- Assessment of Disease Response using CA 125 Tumour Marker [ Time Frame: Disease response assessment at screening/baseline and every 3 weeks if clinically appropriate for tumour type to end of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546921
|Contact: James Spicer, Dr||0207 188 firstname.lastname@example.org|
|Addenbrooke's Hospital, Cambridge||Recruiting|
|Cambridge, United Kingdom|
|Principal Investigator: Bristi Basu, Dr|
|Guy's and St Thomas's Hospital||Recruiting|
|London, United Kingdom, SE1 9RT|
|Principal Investigator: James Spicer, Dr|
|The Royal Marsden Hospital||Recruiting|
|London, United Kingdom|
|Principal Investigator: Udai Banerji, Prof|
|University College London Hospital||Recruiting|
|London, United Kingdom|
|Principal Investigator: Rebecca Kristeleit, Dr|