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

NCT05165433 | Completed Phase 1 FDA Drug

• 3 other identifiers: NG-350A-02MK-3475-C84KEYNOTE-C84
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Epithelial Tumor; Metastatic Cancer

Keywords

NG-350A; Pembrolizumab; Akamis Bio Ltd; PsiOxus; Merck

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (safety and tolerability)

  Assess the safety and tolerability of NG-350A in combination with pembrolizumab by review of adverse events including serious adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.

  100 days after last dose of study drug

Study Arms (1)

All cohorts

EXPERIMENTAL

NG-350A and pembrolizumab

Biological: NG-350A plus Pembrolizumab

Interventions

NG-350A plus Pembrolizumab BIOLOGICAL

Patients receive three doses of NG-350A by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion

Also known as: KEYTRUDA®

All cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Akamis Bio: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (7)

Providence Medical Foundation

Santa Monica, California, 90404, United States

Location

UCLA

Santa Monica, California, 90404, United States

Location

Moffitt-Advent Health Clinical Research Unit

Celebration, Florida, 34747, United States

Location

Perelman Center of Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, Lancashire, L7 8YA, United Kingdom

Location

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (2)

• Naing A, Khalil D, Rosen O, Camidge DR, Lillie T, Ji RR, Stacey A, Thomas M, Rosen L. First-in-human clinical outcomes with NG-350A, an anti-CD40 expressing tumor-selective vector designed to remodel immunosuppressive tumor microenvironments. J Immunother Cancer. 2024 Oct 15;12(10):e010016. doi: 10.1136/jitc-2024-010016.

  PMID: 39414325 DERIVED

• Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.

  PMID: 36897458 DERIVED

MeSH Terms

Conditions

Carcinoma; Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: April 13, 2022
• Primary Completion: August 29, 2025
• Study Completion: September 26, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-03

Locations

US (5); GB (2)