Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)

Completed · Phase 1

Conditions studied: Epithelial Tumor, Metastatic Cancer

In brief

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours.

Key facts

Study ID

NCT05165433

Run by

Akamis Bio

People needed

14

Starts

2022-04-13

Expected to finish

2025-09-26

Last updated by the study team

2025-12-16

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 or 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 v1.1 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
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• All patients
• Provide written informed consent to participate
• Aged 18 years or over on day of signing informed consent
• Predicted life expectancy of ≥6 months
• Adequate lung reserve
• Adequate renal function
• Adequate hepatic function
• Adequate bone marrow/haematological function
• Meeting reproductive status requirements

You may not qualify if…

• Prior or planned allogeneic or autologous bone marrow or tissue/organ transplantation
• Splenectomy
• Active infections requiring systemic anti-infective treatment, physician monitoring/hospital admission 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 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
• Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before first dose of study drug
• Treatment with any other vaccine (including known non live/live-attenuated or non-adenoviral COVID-19 vaccines) in the 7 days before first dose of study drug
• 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/interstitial lung disease that required steroids (or current pneumonitis/interstitial lung disease)
• 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 hospitalization 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
• Use of the following prior therapies/treatments :
• Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or anti-CD40 antibody at any time
• Radiation therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment
• 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 or radiation therapy in the 14 days before the first dose of study treatment
• Bisphosphonate therapy or treatment with Receptor Activator of Nuclear factor Kappa-Β (RANK)-ligand inhibitors for metastatic bone disease is permitted
• All toxicities attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline before the first dose of study treatment. (see protocol for exceptions)

Where it is running

• Providence Medical Foundation — Santa Monica, California, United States
• UCLA — Santa Monica, California, United States
• Moffitt-Advent Health Clinical Research Unit — Celebration, Florida, United States
• Perelman Center of Advanced Medicine — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, Lancashire, United Kingdom
• Churchill Hospital, Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom

Full record on ClinicalTrials.gov

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