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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Andrew Fox
+44 7572 102367
andrew.fox@psioxus.com


Dr Eileen Parkes
+44 7966770228
eileen.parkes@ouh.nhs.uk


Ms Pia Donaldson
+44 1235 835328
irasprojectdeputy@psioxus.com


Study Location:

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Be Part of Research - Trial Details - Phase 1 study of NG-350A plus pembrolizumab in metastatic or advanced epithelial tumours
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Phase 1 study of NG-350A plus pembrolizumab in metastatic or advanced epithelial tumours

Recruiting

Open to: All Genders

Age: Adult

Oxford Wirral Santa Monica, CA Houston, TX

Medical Conditions

Advanced cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study will evaluate the safety (side effects), how the body processes the treatment (pharmacokinetics), and what the treatment does to the body (pharmacodynamic effects) of the drugs NG-350A plus pembrolizumab in patients with cancer.
Worldwide, almost 10 million deaths in 2020 were estimated to be due to cancer. Despite the introduction of multiple new therapies, the overall burden of cancer incidence and mortality is growing worldwide and there remains a critical need for new and effective treatments.
NG-350A is an experimental gene therapy medicinal product.
The other drug used in this study, pembrolizumab, works by changing the action of the immune system, directing it to attack cancer cells. Pembrolizumab belongs to a class of drugs known as monoclonal antibodies. Pembrolizumab is approved for use in the UK.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2022 01 Jun 2025

The study will be conducted with participants in 2 phases. Phase 1a will investigate NG-350A administration by intravenous (IV) infusion in combination with fixed-dose pembrolizumab in a range of tumour types. Phase 1b will further investigate the efficacy and safety of the selected dose regimen in up to three of the tumour types evaluated in phase 1a.


Patients over 18 years, with one of the types of cancer being investigated.

You can take part if:



You may not be able to take part if:


1. Prior or planned allogeneic or autologous bone marrow or tissue/organ transplantation2. Splenectomy3. Active infections requiring systemic anti-infective treatment, physician monitoring/hospital admission or recurrent fevers (>38.0ËšC) associated with a clinical diagnosis of active infection within 20 days of the anticipated first dose of study drug. Patients who have had an active infection requiring systemic therapy, but not hospital admission, which has resolved at least 10 days before the anticipated first dose of study drug are eligible4. Treatment with the antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 10 days prior to the first dose of study treatment; or pegylated interferon in the 4 weeks before the first dose of study treatment5. Known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Known history of HIV infection (no testing for HIV, hepatitis B or hepatitis C is required unless mandated by local health authority) 6. Patients who have active autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving chronic systemic immunosuppressive treatment (including steroid therapy in doses exceeding 10 mg daily of prednisone equivalent)7. Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before first dose of study drug


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Churchill Hospital
    Churchill Hospital Old Road Headington
    Oxford
    OX3 7LE
  • Clatterbridge Cancer Centre
    Clatterbridge Hospital Clatterbridge Road
    Wirral
    CH63 4JY
  • University of California, Los Angeles (UCLA) - Medical Center
    2020 Santa Monica Blvd Suite 540
    Santa Monica, CA
    90404
  • MD Anderson Cancer Center
    Division of Cancer Medicine, Unit 455 515 Holcombe Blvd
    Houston, TX
    77030-4009

Benefits:
There will be no direct medical benefit, we hope the information learned from this study will benefit other participants with cancer in the future.
Risks:
It is not possible to predict all side-effects but based on prior studies/literature. Kidney damage, breathing problems, intestinal blockages, abnormal blood clotting tests (not associated with bleeding/clotting) and cytokine release syndrome (see ICF) are considered important risks in this study. Successful mitigation strategies have been established to reduce the risk of these side-effects (eg not enrolling patients most at risk, extra monitoring & modifying dosing schedules). Pembrolizumab is approved for treating the cancer types in this study; further unknown risks may occur when it is combined with NG-350A. Prior studies with related viral vectors + pembrolizumab have not identified new risks. A complete list of potential risks and side-effects are provided in the ICF. Patients will be closely monitored during the study and if the patient’s condition worsens or disease progression occurs, study treatment will be discontinued. As relatively frequent visits are required, visit windows are in place to allow patients to attend at the most convenient times for them; some visits may be by phone. Patients need to have routine blood draws (max 122 mL drawn per visit), CT or MRI scans and biopsies. These are all common procedures which would likely be carried out as part of the patient’s routine care. All procedures will be carried out by trained professionals. Biopsies can cause pain and so the area to be biopsied is numbed with a local anaesthetic and painkillers may be prescribed. The effect of NG-350A on babies before they are born, or on breastfeeding children is not known. Patients who are pregnant, planning pregnancy or are breastfeeding, will not be included in the study. A number or requirements are in place to prevent pregnancy.

Dr Eileen Parkes
+44 7966770228
eileen.parkes@ouh.nhs.uk


Ms Pia Donaldson
+44 1235 835328
irasprojectdeputy@psioxus.com


Dr Andrew Fox
+44 7572 102367
andrew.fox@psioxus.com



The study is sponsored by PsiOxus Therapeutics Ltd. and funded by PsiOxus Therapeutics Ltd.



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Read full details for Trial ID: ISRCTN94964671

Or CPMS 52187

Last updated 04 July 2022

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