* First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine
Research type
Research Study
Full title
A Phase 1, Multicenter, Open-label, Nonrandomized, First-in-human Study of OVM-200 as a Therapeutic Vaccine in Patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer, Ovarian Cancer, and Prostate Cancer
IRAS ID
299207
Contact name
Martin Forster
Contact email
Sponsor organisation
Oxford Vacmedix UK Ltd.
Eudract number
2021-001545-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 23 days
Research summary
Survivin is a protein which blocks programmed cell death. It is overexpressed in many solid tumour cells and thus makes them a target for Cytotoxic T Lymphocytes (CTL). OVM-200 is a vaccine which will stimulate the development of specific CTL which will target cells expressing survivin. It thus becomes a therapeutic agent for the treatment of many solid tumours including lung, prostate and ovary.
OVM-200 will be tested in humans for the first time in Study OVM-200-100. Up to 52 patients aged 18-75 with prostate, lung or ovarian cancer will be enrolled in the Study to find out if OVM-200 is safe to continue studying it in patients with cancer. The Study consists of 2 parts: a dose escalation part and a dose expansion part. In the dose escalation part, up to 4 increasing doses of OVM-200 will be evaluated in small groups of cancer patients to find the recommended dose for the expansion part. The recommended dose of OVM-200 will then be given to cancer patients in the dose expansion part to confirm safety and understand how effective it is against their disease and if there are any side effects.
Patients who agree to participate in the Study and pass screening will receive 3 doses of OVM-200 in total at 2-week intervals as an injection under the skin. After completing treatment with OVM-200 patients will be followed up for side effects and to monitor changes in their cancer. Patients will stay on the Study for about 6 months in total during which they will have 10 hospital visits. The Study will run at around 5 sites in the UK.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0342
Date of REC Opinion
23 Jul 2021
REC opinion
Further Information Favourable Opinion