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First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody) (FORTITUDE)

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ClinicalTrials.gov Identifier: NCT03852511
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd

Study Description
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Brief Summary:
This study will evaluate the safety, tolerability and preliminary efficacy and also pharmacokinetics, immunogenicity and other pharmacodynamic effects to elucidate the mechanism of action of NG-350A in patients with advanced or metastatic epithelial tumours.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Epithelial Tumor Biological: NG-350A Phase 1

Detailed Description:
Phase Ia of this study is a dose escalation and safety expansion phase, investigating NG-350A administration by intratumoural (IT) injection and intravenous (IV) infusion. Phase Ib of this study will investigate efficacy in patients with specific epithelial tumour types.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label, Non Randomised First in Human Study of NG-350A in Patients With Metastatic or Advanced Epithelial Tumours
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intratumoural (Cohort 1)
Patients will receive a single dose of NG-350A by IT injection.
 Biological: NG-350A
NG-350A is oncolytic adenoviral vector which expresses a full length agonist anti-CD40 antibody at the site of virus replication.
Experimental: Intratumoural (Cohort 2)
Patients will receive one cycle of multiple doses of NG-350A by IT injection.
 Biological: NG-350A
NG-350A is oncolytic adenoviral vector which expresses a full length agonist anti-CD40 antibody at the site of virus replication.
Experimental: Intravenous
Patients will receive three single doses of NG-350A by IV infusion.
 Biological: NG-350A
NG-350A is oncolytic adenoviral vector which expresses a full length agonist anti-CD40 antibody at the site of virus replication.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (safety and tolerability) [ Time Frame: Throughout study to end of study treatment visit (Day 57) ]
    Characterise the safety and tolerability of NG-350A by reviewing reported Adverse Events (AEs) and Serious Adverse Events (SAEs).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent to participate
  2. Aged 18 years or over
  3. Histologically or cytologically documented metastatic or advanced epithelial cancer (carcinoma or adenocarcinoma) that has relapsed from, or is refractory to, standard treatment, or for which no standard treatment is available

  4. a) For patients undergoing surgical excision/resection:

    • Tumour deemed accessible and safe for biopsy by the Investigator
    • Willing to consent to biopsies and surgical procedure

    • Patient able to undergo surgical procedure and appropriate anaesthesia

      b) For patients not undergoing surgical excision/resection:

    • Tumour deemed accessible and safe for biopsy by the Investigator
    • Willing to consent to tumour biopsies
  5. Safety expansion and efficacy cohorts only: at least one measurable site of disease according to RECIST criteria.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Predicted life expectancy of 3 months or more
  8. Ability to comply with study procedures in the Investigator's opinion
  9. Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
  10. Adequate lung reserve
  11. Adequate renal function
  12. Adequate hepatic function
  13. Adequate bone marrow function
  14. Prothrombin time and aPTT within normal range or international normalised ratio ≤1.5, as appropriate
  15. Meeting the reproductive requirements of the study

Exclusion Criteria:

  1. Known history or evidence of significant immunodeficiency due to underlying illness.
  2. Splenectomy
  3. Prior allogeneic or autologous bone marrow or organ transplantation
  4. Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
  5. Active viral disease or positive test for hepatitis B virus using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV RNA or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS; testing is not required in the absence of history
  6. Use of the following antiviral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment
  7. Administration of an investigational drug in the 28 days, or six half-lives (whichever is longer) before the first dose of study treatment
  8. Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational therapy in the 28 days before the first dose of study treatment.
  9. 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
  10. Symptomatic brain metastases or any leptomeningeal metastasis that is symptomatic and/or requires treatment. Patients with brain metastases are eligible if these have been locally treated (surgery, radiotherapy).
  11. Any history of renal disease or renal injury or autoimmune disease.
  12. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results
  13. History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 12 months before the first dose of study treatment
  14. History of DVT or pulmonary embolus in the 12 months before the first dose of study treatment
  15. History of significant bleeding requiring hospitalisation in the 12 months before the first dose of study treatment
  16. Patients receiving therapeutic or prophylactic anticoagulation therapy
  17. Previous treatment with enadenotucirev or an anti-CD40 antibody
  18. Known allergy to NG-350A transgene products or formulation
  19. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  20. Patients at an increased risk due to tumour flare
  21. Clinically suspected or radiographic evidence of lymphangitic carcinomatosis
  22. History of idiopathic pulmonary fibrosis, pneumonitis, organising pneumonia, or evidence of active pneumonitis
  23. Dependence on supplemental oxygen use
  24. Treatment with any immune checkpoint inhibitors or immune-stimulatory treatment in the 6 weeks before the first dose of study treatment
  25. Penetrating tumour infiltration of major blood vessels, pericardium, gastrointestinal tract or other hollow organs that may lead to perforation due to tumour necrosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852511


Contacts
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Contact: PsiOxus Therapeutics +44 1235835328 enquiries@psioxus.com

Locations
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United States, California
University of California, Los Angeles (UCLA) Recruiting
Santa Monica, California, United States, 90404
Contact: Lee Rosen, MD    310-633-8400    lrosen@mednet.ucla.edu   
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Ross Camidge       Ross.camidge@cuanschutz.edu   
United States, New York
Memorial Sloan Kettering Cancer Center (MSKCC) Recruiting
New York, New York, United States, 10038
Contact: Danny Khalil, MD       khalild@mskcc.org   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Aung Naing, MD    713-563-0803    anaing@mdanderson.org   
Sponsors and Collaborators
PsiOxus Therapeutics Ltd
Investigators
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Principal Investigator: Aung Naing, MD The University of Texas MD Anderson Cancer Center
More Information
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Responsible Party: PsiOxus Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT03852511    
Other Study ID Numbers: NG-350A-01
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PsiOxus Therapeutics Ltd:
metastatic; epithelial; virus; advanced
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Neoplasms
Pathologic Processes
 Neoplasms by Histologic Type
Antibodies
Immunologic Factors
Physiological Effects of Drugs