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Trial record 1 of 2 for:    NG-641
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A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck (MOAT)

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ClinicalTrials.gov Identifier: NCT04830592
Recruitment Status : Not yet recruiting
First Posted : April 5, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd

Study Description
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Brief Summary:
A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: NG-641 Biological: Pembrolizumab Phase 1

Detailed Description:

Part A (NG-641 monotherapy): Up to 18 patients will be dosed with intravenous NG-641. Patients will then proceed to planned surgical resection.

Part B (NG-641 and pembrolizumab): Up to 30 patients will be dosed with intravenous NG-641 before receiving a single dose of pembrolizumab. Patients will then proceed to planned surgical resection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label, Dose-escalating, Phase Ib, Study of Intravenous Dosing of NG-641, as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
NG-641 monotherapy
 Biological: NG-641
Patients receive three doses of NG-641 by intravenous infusion.
Experimental: Part B
NG-641 and pembrolizumab
 Biological: NG-641
Patients receive three doses of NG-641 by intravenous infusion.

Biological: Pembrolizumab
Patients receive three doses of NG-641 by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (safety and tolerability) [ Time Frame: End of Study Treatment Visit (Day 57) ]
    Assess the safety and tolerability of NG-641 by review of adverse events (AEs), serious adverse events, AEs resulting in delays to planned surgery, AEs leading to study treatment or study discontinuation and AEs resulting in death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed or recurrence of clinical stage III-IVb histologically confirmed oral cavity, larynx, hypopharynx or oropharynx squamous cell carcinoma of the head and neck (SCCHN)
  2. Disease is considered resectable, definitive surgery is planned in the next 8 weeks from screening, and the patient is willing to undergo surgery
  3. Known human papillomavirus (HPV) status for oropharyngeal cancer
  4. Provide written informed consent to participate
  5. Aged 18 years or over
  6. Willing to consent to tumour biopsies at baseline
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  8. Ability to comply with study procedures in the Investigator's opinion
  9. Adequate renal function
  10. Adequate hepatic function
  11. Adequate bone marrow function
  12. Coagulation profile within the normal range
  13. Meeting the reproductive status requirements of the study

Exclusion Criteria:

  1. Prior allogeneic or autologous bone marrow or organ transplantation
  2. Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection. Active infection requiring systemic therapy within 1 week of the anticipated first dose of study drug.
  3. Active viral disease or positive test for hepatitis B virus using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS
  4. 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 systemic immunosuppressive treatment
  5. Treatment with any COVID-19 vaccine in the 28 days before the first dose of NG-641, unless the vaccine is known to not be based on an adenoviral vector (e.g. messenger RNA (mRNA) vaccines)
  6. Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before first dose of NG-641
  7. History of clinically significant chronic liver disease
  8. History of clinically significant interstitial lung disease (including pneumonitis)
  9. History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
  10. Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon (PEG-IFN) in the 14 days before the first dose of study treatment
  11. Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection
  12. Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding or risk factors for gastrointestinal bleeding, infectious or inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event, history or evidence of haemoptysis, or significant cardiovascular or cerebrovascular event
  13. Any known coagulopathy
  14. Prior history of bowel obstruction, or infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
  15. Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational drug/therapy in the 28 days before the first dose of study treatment
  16. Other prior malignancy active within the previous 3 years, except for local or organ confined early stage cancer that has been definitively treated with curative intent, 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
  17. Tumour location/extent considered by the Investigator to present a significant risk of airway obstruction if tumour flare or necrosis were to occur (e.g. an initial increase in tumour size that may lead to intestinal, airway or ureter obstruction, or penetrating tumour infiltration of major blood vessels, or other hollow organs potentially at risk of perforation)
  18. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results
  19. Previous treatment with any other enadenotucirev-based therapy, or fibroblast activation protein (FAP) targeting agent
  20. Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody
  21. Any other medical or psychological condition that would affect the patient's ability to comply with all visits and assessments, or compromise ability to give informed consent
  22. Related to or a dependent of the site staff, or a member of the site staff
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830592


Contacts
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Contact: PsiOxus Therapeutics +44 (0)1235 835 328 enquiries@psioxus.com

Locations
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United Kingdom
Cardiff & Vale University LHB
Cardiff, United Kingdom
Contact: John Chester, Prof.         
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
Contact: Christian Ottensmeier, Prof.         
The Royal Marsden Hospital
London, United Kingdom
Contact: Kevin Harrington, Prof.         
Sponsors and Collaborators
PsiOxus Therapeutics Ltd
Investigators
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Principal Investigator: Christian Ottensmeier, Prof. The Clatterbridge Cancer Centre
More Information
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Responsible Party: PsiOxus Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT04830592    
Other Study ID Numbers: NG-641-02
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by PsiOxus Therapeutics Ltd:
Squamous cell carcinoma of the head and neck
SCCHN
NG-641
Pembrolizumab
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents