Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT05104515

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine

Led by Oxford Vacmedix UK Ltd. · Updated on 2025-02-14

36

Participants Needed

4

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed metastatic or locally advanced inoperable non-small cell lung cancer, ovarian cancer, or prostate cancer
  • Patients must have received at least one approved cancer therapy
  • Patients must have exhausted current treatment options, be in a planned treatment-free interval after a set treatment course, or be stable on antihormonal treatment for prostate cancer
  • Not receiving active cancer treatment aside from supportive therapies or androgen deprivation therapy for prostate cancer
  • Have at least one measurable lesion suitable for repeated imaging assessment (for non-small cell lung cancer only)
  • Age between 18 and 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Predicted life expectancy of at least 3 months
  • Adequate bone marrow, kidney, and liver function
Not Eligible

You will not qualify if you...

  • Known significant immunodeficiency or underlying illness causing immune problems
  • Use of corticosteroids over 10 mg daily or other immunosuppressive drugs within 14 days before first dose
  • History or active autoimmune disease requiring systemic or immunosuppressive treatment, except certain stable conditions
  • Prior anticancer vaccine or immune checkpoint inhibitor therapy within 28 days before first dose
  • Use of investigational drugs within 28 days or 6 half-lives before first dose
  • Major surgery, chemotherapy, or radiation within 28 days before first dose
  • Active infection requiring antibiotics or recurrent fever over 38.0°C with infection diagnosis
  • Active viral infection including hepatitis B, hepatitis C, or HIV
  • Receipt of any vaccine within 28 days before first dose
  • Other prior cancers within 3 years except certain treated early-stage cancers
  • Symptomatic brain metastases or leptomeningeal metastasis
  • Serious uncontrolled medical conditions that increase risk or interfere with study
  • History of allergic reaction to OVM-200 or its components

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University College London Hospitals NHS Foundation Trust

London, London, United Kingdom, W1T 7HA

Actively Recruiting

2

Sarah Cannon Research Institute UK

London, United Kingdom

Actively Recruiting

3

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Actively Recruiting

4

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine | DecenTrialz