We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05165433
Recruitment Status : Recruiting
First Posted : December 21, 2021
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Akamis Bio

Tracking Information
First Submitted Date  ICMJE December 7, 2021
First Posted Date  ICMJE December 21, 2021
Last Update Posted Date January 18, 2023
Actual Study Start Date  ICMJE April 13, 2022
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2021)
Incidence of adverse events (safety and tolerability) [ Time Frame: 100 days after last dose of study drug ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)
Official Title  ICMJE 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
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.
Detailed Description Phase 1a will investigate NG-350A administration by intravenous (IV) infusion in combination with fixed-dose pembrolizumab in a range of tumour types. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epithelial Tumor
  • Metastatic Cancer
Intervention  ICMJE Biological: NG-350A plus Pembrolizumab
Patients receive three doses of NG-350A by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion.
Study Arms  ICMJE Experimental: All cohorts
NG-350A and pembrolizumab
Intervention: Biological: NG-350A plus Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2021)
198
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide written informed consent to participate
  2. Aged 18 years or over
  3. One of eleven histologically or cytologically confirmed metastatic/advanced carcinomas or adenocarcinomas that has progressed after at least one line of systemic therapy and are incurable by local therapy
  4. At least one measurable site of disease according to RECIST v1.1 criteria
  5. Prior treatment with a PD-1/PD-L1 inhibitor
  6. Tumour accessible for biopsy, and patient willing to consent to tumour biopsies
  7. Ability to comply with study procedures in the Investigator's opinion
  8. ECOG performance status 0 or 1
  9. Predicted life expectancy of ≥6 months
  10. Adequate lung reserve
  11. Adequate renal function
  12. Adequate hepatic function
  13. Adequate bone marrow/haematological function
  14. Coagulation profile within the normal range
  15. Meeting reproductive status requirements

Exclusion Criteria:

  1. Prior or planned allogeneic or autologous bone marrow or tissue/organ transplantation
  2. Splenectomy
  3. Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
  4. Known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Known history of HIV infection (no testing for HIV, hepatitis B or hepatitis C is required unless mandated by local health authority).
  5. Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 10 days prior to the first dose of study treatment; or pegylated interferon (PEG-IFN) in the 4 weeks before the first dose of study treatment
  6. 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.
  7. Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before first dose of study drug
  8. 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
  9. History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
  10. History of clinically significant interstitial lung disease or non-infectious pneumonitis/interstitial lung disease that required steroids
  11. Lymphangitic carcinomatosis
  12. 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, history or evidence of haemoptysis, significant cardiovascular or cerebrovascular event and any history of bleeding requiring an investigative procedure (e.g. endoscopy), transfusion or hospitalization in the 12 months before the first dose of study treatment
  13. Any of the following in the 12 months before the first dose of study treatment: pulmonary embolism, deep vein thrombosis or other uncontrolled thromboembolic event
  14. Tumour location/extent considered by the Investigator to present a significant risk of a 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)
  15. Use of the following prior therapies/treatments:

    1. Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or anti-CD40 antibody at any time
    2. Radiation therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment
    3. 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)
    4. 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
    5. 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
    6. Bisphosphonate therapy or treatment with Receptor Activator of Nuclear factor Kappa-Β (RANK)-ligand inhibitors for metastatic bone disease is permitted
  16. All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to Grade 1 or baseline
  17. 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
  18. Known allergy or hypersensitivity to NG-350A transgene, pembrolizumab and/or any of its excipients or other monoclonal antibodies
  19. 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
  20. Known active central nervous system metastases and/or carcinomatous meningitis.
  21. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: PsiOxus Therapeutics +441235835328 enquiries@akamisbio.com
Contact: Pia Donaldson +441235835328 pia.donaldson@akamisbio.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05165433
Other Study ID Numbers  ICMJE NG-350A-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Akamis Bio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Akamis Bio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE Not Provided
PRS Account Akamis Bio
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP