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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
University College London Hospitals NHS Foundation Trust
London W1T 7HA, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
