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Epithelial TumorPhase 1FORTIFYNCT05165433

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

A Phase 1 study testing NG-350A plus Pembrolizumab in people with Epithelial Tumor and Metastatic Cancer, run by Akamis Bio at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epithelial Tumor, Metastatic Cancer
What is being tested?
NG-350A plus Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
7 sitesin 2 countries
Study dates
13 Apr 2022to 26 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)
  • Participants with a history of radiation pneumonitis are not eligible for inclusion
  • Discontinuation from prior treatment with an anti-PD-1 or anti PD L1/PD-L2 agent, or an agent directed to another stimulatory or co-inhibitory T cell receptor, due to a Grade ≥3 immune-related AE
  • Known allergy or hypersensitivity (Grade ≥3) to NG-350A transgene, pembrolizumab and/or any of its excipients or other monoclonal antibodies
  • Known hypersensitivity to both cidofovir and valacyclovir
  • Other prior malignancy active within the previous 3 years (see protocol for exceptions)
  • Known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and have not required steroid treatment for at least 14 days prior to first dose of study treatment
  • Positive pregnancy test prior to treatment (a serum test must be performed within 24 hours)
  • History or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States5 sites

  • Moffitt-Advent Health Clinical Research Unit

    Celebration, Florida, 34747

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Perelman Center of Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Providence Medical Foundation

    Santa Monica, California, 90404

  • UCLA

    Santa Monica, California, 90404

Other trials in United States

United Kingdom2 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, Lancashire, L7 8YA

  • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Multicentre, Open-label, Non-randomized, Phase 1a/1b Study of NG-350A, a Tumour-selective Anti-CD40-expressing Adenoviral Vector, in Combination With Pembrolizumab in Patients With Metastatic or Advanced Epithelial Tumours

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.

Read the detailed description

Phase 1a will investigate NG-350A administration by intravenous (IV) infusion in combination with fixed-dose pembrolizumab in patients with metastatic or advanced tumours.

Phase 1b will further investigate the efficacy and safety of the selected dose regimen in up to three of the tumour types evaluated in Phase 1a.

Being tested
NG-350A plus Pembrolizumab
Keywords
NG-350A, Pembrolizumab, Akamis Bio Ltd, PsiOxus, Merck
Medical subject headings
Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NG-350A plus PembrolizumabBiological

    Also called KEYTRUDA®

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

Study groups in NCT05165433
Study groupRoleWhat they receive
All cohortsExperimentalNG-350A and pembrolizumab
Receives: Biological: NG-350A plus Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 100 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start13 Apr 2022
  3. Primary completion29 Aug 2025
  4. Study completion26 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165433
Sponsor's protocol ID
NG-350A-02
Other IDs
MK-3475-C84, KEYNOTE-C84
Acronym
FORTIFY
Status last verified
Mar 2025
First submitted
7 Dec 2021
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39414325

  • 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.

    PubMed 36897458

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NG-350A plus Pembrolizumab in people with Epithelial Tumor and Metastatic Cancer, run by Akamis Bio at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (safety and tolerability) (time frame: 100 days after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165433, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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