OVM-200 for Advanced Ovarian, Lung, or Prostate Cancer
First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine
Recruiting
Phase 1Interventional Study
Prostate CancerNon Small Cell Lung CancerOvarian Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Oxford Vacmedix UK Ltd. · Industry
Who this trial is looking for
This trial is looking for patients with advanced ovarian, lung, or prostate cancer to test a new treatment called OVM-200. Participants will receive the treatment through injections and will be monitored for safety and effectiveness over approximately six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with advanced ovarian, lung, or prostate cancer.
I have already received at least one approved cancer treatment.
I have at least one measurable lesion that can be assessed.
I am not currently receiving active cancer treatment.
I have a life expectancy of at least 3 months.
I have good function of my bone marrow, kidneys, and liver.
You may not be able to join if
I have a history of significant immunodeficiency.
I have an active autoimmune disease.
I have received an anticancer vaccine or certain immunotherapy drugs recently.
I have had major surgery or cancer treatment in the last 28 days.
I have an active infection that needs treatment.
I have a positive test for certain viral infections, including HIV.
I have received any vaccine in the last 28 days.
I have any serious medical disorder that could affect my safety.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 wil…
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.
Trial Locations
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Eligibility 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 treatme…
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.
Contacts
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