Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours

Completed · Phase 1

Conditions studied: Metastatic Cancer, Epithelial Tumor

In brief

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab (or standard of care PD-1 inhibition) in patients with metastatic or advanced epithelial tumours. The purpose is to characterize the safety and tolerability of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours and to determine the recommended dose of NG-641 in combination with nivolumab for further development in patients with metastatic or advanced epithelial tumours

Key facts

Study ID

NCT05043714

Run by

Akamis Bio

People needed

30

Starts

2021-12-01

Expected to finish

2024-10-04

Last updated by the study team

2025-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase 1a:
• Patients must have histologically or cytologically documented metastatic/advanced epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.
• At least one measurable site of disease according to RECIST Version 1.1 criteria; this lesion must be either (i) outside a previously irradiated area or (ii) progressive if it is in a previously irradiated area
• Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
• All patients:
• Provide written informed consent to participate
• Ability to comply with study procedures in the Investigator's opinion
• Aged 18 years or over
• ECOG performance status 0 or 1
• Predicted life expectancy of ≥6 months
• Adequate lung reserve
• Adequate renal function
• Adequate hepatic function
• Adequate bone marrow function
• Meeting reproductive status requirements

You may not qualify if…

• Prior or planned allogeneic or autologous bone marrow or organ transplantation
• Splenectomy
• Active infections requiring antibiotics, physician monitoring or systemic therapy within 1 week of the anticipated first dose of study drug, or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
• Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment; or pegylated interferon in the 4 weeks before the first dose of study treatment
• Known history of hepatitis B infection or known active hepatitis C infection . Known history of HIV infection
• Patients who have active, known or suspected autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving long-term systemic immunosuppressive treatment
• Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before the first dose of NG-641 or nivolumab
• Treatment with any other vaccine (including known non-live/live-attenuated and non-adenoviral COVID-19 vaccines) in the 7 days before the first dose of NG-641
• History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
• History of clinically significant interstitial lung disease or non-infectious pneumonitis
• Lymphangitic carcinomatosis
• Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
• Any known CTCAE Grade ≥2 coagulation abnormality/coagulopathy
• Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the 6 months before the first dose of study treatment
• Grade 3 or 4 gastrointestinal bleeding (or risk factors for gastrointestinal bleeding), haemoptysis, or any history of bleeding requiring an investigative procedure, transfusion or hospitalisation in the 6 months before the first dose of study treatment
• Tumour location/extent considered by the Investigator to present a significant risk if tumour flare or necrosis were to occur
• Known retinopathy, including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction
• Active clinically severe depression
• Use of the following prior therapies/treatments
• Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or fibroblast activation protein (FAP) targeting agent at any time
• Treatment with an investigational or licensed anti-cancer monoclonal antibody (mAb), immune checkpoint inhibitor, immune stimulatory treatment, or other biological therapy in the 28 days prior to the first dose of study treatment
• Prior anti-PD-1/PD-L1 therapy is permitted without a 'washout' phase
• Treatment with an investigational or licensed chemotherapy, targeted small molecule, or other investigational drug in the 14 days or five half-lives (whichever is shorter) before the first dose of study treatment
• Major surgery in the 28 days before the first dose of study treatment
• Radiation therapy in the 14 days before the first dose of study treatment

Where it is running

• Providence Medical Foundation — Fullerton, California, United States
• UCLA Department of Medicine — Santa Monica, California, United States
• Moffitt-Advent Health Clinical Research Unit — Celebration, Florida, United States
• University of Cincinnati Cancer Center — Cincinnati, Ohio, United States
• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, Lancashire, United Kingdom
• Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom

Full record on ClinicalTrials.gov

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