Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

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

Sponsor: Oxford Vacmedix UK Ltd.

NCT ID: NCT05104515

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
OVM-200 (biological)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
OVM-200 — biological: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
36
Started
2021-11-01
Last checked
2025-02

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Phase1 - 36 participants
  • • OVM-200 will be tested in humans for the first time in Study OVM-200-100

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with prostate cancer

Where?

  • • London - University College London Hospitals NHS Foundation Trust
  • • London - Sarah Cannon Research Institute UK
  • • Manchester - The Christie NHS Foundation Trust
  • • Oxford - Oxford University Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Prostate CancerNon Small Cell Lung CancerOvarian Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

PD-L1CD137or positive

What the study is looking for

  • ✓3\. At least 1 measurable lesion that can be accurately assessed at baseline by computed tomography (CT)/magnetic...
  • ✓4\. Age ≥ 18 years and ≤ 75 years. 5. activity scale (ECOG) performance status ≤ 2 (Section 7.2.6).
  • ✓6\. Predicted life expectancy ≥ 3 months. 7. Adequate bone marrow, kidney, and liver function.

Who cannot take part

  • ✗Administration of an investigational drug in the 28 days or 6 half-lives (whichever is longer) before the first dose...
  • ✗Major surgery or treatment with any drug treatment, or radiotherapy for cancer in the 28 days before the first...
  • ✗Active infection requiring antibiotics or physician monitoring, or recurrent fevers (\> 38.0°C) associated with a...
  • ✗Receipt of any vaccine within 28 days before the first dose of the study treatment.
  • ✗causing symptoms brain metastases or any leptomeningeal metastasis.
See the full criteria
Inclusion Criteria: * 1\. Histologically confirmed metastatic or locally advanced inoperable NSCLC, ovarian cancer, or prostate cancer that have already received at least 1 line of approved cancer therapy and either: exhausted current recognized treatment options; or are stable in a planned treatment-free interval following completion of a set course of treatment; or in the case of prostate cancer, are currently stable on an antihormonal treatment. 2\. Are not receiving active cancer treatment other than supportive therapies or androgen deprivation therapies for prostate cancer, which may be continued, and, in the opinion of the investigator, are not anticipated to require further approved cancer treatment options until the Week 8 assessment (up to 9 weeks) after the first dose of OVM-200 per standard of care. 3\. At least 1 measurable lesion that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment (NSCLC only). 4\. Age ≥ 18 years and ≤ 75 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Section 7.2.6). 6\. Predicted life expectancy ≥ 3 months. 7. Adequate bone marrow, renal, and hepatic function. Exclusion Criteria: 1. Known history or evidence of significant immunodeficiency due to underlying illness. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisolone equivalent) or other immunosuppressive medications within 14 days of the first dose of study drug. Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of autoimmune disease. 2. Patients with a history of or active, known, or suspected autoimmune disease or a syndrome that requires systemic or immunosuppressive agents. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol. 3. Prior therapy with an anticancer vaccine; anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody; or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways in the 28 days before the first dose of study drug. 4. Administration of an investigational drug in the 28 days or 6 half-lives (whichever is longer) before the first dose of study drug. 5. Major surgery or treatment with any chemotherapy, or radiation therapy for cancer in the 28 days before the first dose of study drug. 6. Active infection requiring antibiotics or physician monitoring, or recurrent fevers (\> 38.0°C) associated with a clinical diagnosis of active infection. 7. Active viral disease, positive test for hepatitis B virus using hepatitis B surface antigen test, or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid or HCV antibody test indicating acute or chronic infection. Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome; testing is not required in the absence of history. 8. Receipt of any vaccine within 28 days before the first dose of study drug. 9. Other prior malignancy within the previous 3 years, except for local or organ-confined early stage cancer that has been definitively treated with curative intent and does not require ongoing treatment, has no evidence of residual disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety and tolerability. 10. Symptomatic brain metastases or any leptomeningeal metastasis. 11. Any serious or uncontrolled medical disorder (including cardiovascular, respiratory, renal, or autoimmune disease) that, in the opinion of the investigator or the medical monitor, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy, or interfere with the interpretation of study results. 12. History of allergic reaction or hypersensitivity to any component of the OVM-200 therapeutic vaccine or adjuvant.

Where Is This Study? (4 UK sites)

University College London Hospitals NHS Foundation Trust

London W1T 7HA, United Kingdom

Recruiting
Site contact (verified)
Martin Forster, MBBS FRCP PhDPrincipal Investigator

Sarah Cannon Research Institute UK

London, United Kingdom

Recruiting
Site contact (verified)
Anja WilliamsPrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Fiona Thistlethwaite, MB, BChir, PhD, MRCPPrincipal Investigator

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Mark TuthillPrincipal Investigator
Data sourced from ClinicalTrials.gov · Last verified: 2025-02