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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
The first part (Phase 1a) comprises a first-in-human (FIH) multiple-dose, sequential-cohort 3+3 design to establish a dose of OVM-200 that is safe and tolerable, and that elicits an immune response in humans. This dose will be taken forward into the second part (Phase 1b) of the study. Phase 1b will further assess the safety and tolerability of the selected dose and investigate the immune and tumour response in 3 expansion cohorts of additional patients with NSCLC, ovarian cancer, and prostate cancer.
University College London Hospitals NHS Foundation Trust
London, London, United Kingdom
RECRUITINGSarah Cannon Research Institute UK
London, United Kingdom
RECRUITINGThe Christie NHS Foundation Trust
Manchester, United Kingdom
RECRUITINGOxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
NOT_YET_RECRUITINGThe primary endpoint (safety and tolerability) for this study is the occurrence and intensity of adverse events.
Time frame: 24 Weeks
Immune response to OVM 200 as measured by ELISpot for T cell responses and ELISA for antibody responses.
Time frame: 24 Weeks
Disease progression and tumour response evaluated using Response Evaluation Criteria in Solid Tumour (RECIST)
Time frame: 24 Weeks
In ovarian cancer patients, tumour marker CA-125 measured and evaluated according to Gynecologic Cancer Intergroup Criteria (GCIC).
Time frame: 24 Weeks
In prostate cancer patients, tumour markers prostate-specific antigen (PSA) and total alkaline phosphatase (ALP) as per PCWG3 response criteria.
Time frame: 24 Weeks
Survivin expression will be correlated to response (based on immune response, tumour assessments, and tumour marker measurements) achieved after OVM-200 administration.
Time frame: 24 Weeks
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