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 :
Recruiting
First Posted : April 5, 2021
Last Update Posted : December 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Squamous Cell Carcinoma of the Head and Neck | Biological: NG-641 Biological: Pembrolizumab | Phase 1 |
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 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 |
Actual Study Start Date : | November 4, 2021 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | September 2022 |

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. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
- Disease is considered resectable, definitive surgery is planned in the next 8 weeks from screening, and the patient is willing to undergo surgery
- Known human papillomavirus (HPV) status for oropharyngeal cancer
- Provide written informed consent to participate
- Aged 18 years or over
- Willing to consent to tumour biopsies at baseline
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Ability to comply with study procedures in the Investigator's opinion
- Adequate renal function
- Adequate hepatic function
- Adequate bone marrow function
- Coagulation profile within the normal range
- Meeting the reproductive status requirements of the study
Exclusion Criteria:
- Prior allogeneic or autologous bone marrow or organ transplantation
- 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.
- 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
- 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
- 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)
- Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before first dose of NG-641
- History of clinically significant chronic liver disease
- History of clinically significant interstitial lung disease (including pneumonitis)
- History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
- 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
- Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection
- 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
- Any known coagulopathy
- Prior history of bowel obstruction, or infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
- 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
- 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
- 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)
- 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
- Previous treatment with any other enadenotucirev-based therapy, or fibroblast activation protein (FAP) targeting agent
- Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody
- 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
- Related to or a dependent of the site staff, or a member of the site staff

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
Contact: PsiOxus Therapeutics | +44 (0)1235 835 328 | enquiries@psioxus.com |
United Kingdom | |
Cardiff & Vale University LHB | Not yet recruiting |
Cardiff, United Kingdom | |
Contact: John Chester, Prof. | |
The Clatterbridge Cancer Centre | Recruiting |
Liverpool, United Kingdom | |
Contact: Christian Ottensmeier, Prof. | |
The Royal Marsden Hospital | Not yet recruiting |
London, United Kingdom | |
Contact: Kevin Harrington, Prof. |
Principal Investigator: | Christian Ottensmeier, Prof. | The Clatterbridge Cancer Centre |
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: | December 9, 2021 |
Last Verified: | November 2021 |
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 |
Squamous cell carcinoma of the head and neck SCCHN NG-641 Pembrolizumab |
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 |