Loading clinical trials...

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1, Multicentre, Open-label, Nonrandomised, 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

NCT05104515•Oxford Vacmedix UK Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (4)

University College London Hospitals NHS Foundation Trust

London, London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Key Dates

Start Date

November 1, 2021

Primary Completion Date

November 30, 2025

Completion Date

January 31, 2026

Last Updated

February 14, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate CancerNon Small Cell Lung CancerOvarian Cancer

Interventions

OVM-200

BIOLOGICAL

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors