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Trial record 1 of 1 for:    NG-641
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First in Human Study With NG-641, an Oncolytic Transgene Expressing Adenoviral Vector

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. Identifier: NCT04053283
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : February 10, 2020
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd

Tracking Information
First Submitted Date  ICMJE August 9, 2019
First Posted Date  ICMJE August 12, 2019
Last Update Posted Date February 10, 2020
Actual Study Start Date  ICMJE January 23, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
Incidence of adverse events (safety and tolerability) in study NG-641 [ Time Frame: End of study treatment visit, Day 85 ]
Assess the safety and tolerability of NG-641 by review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, severe 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 First in Human Study With NG-641, an Oncolytic Transgene Expressing Adenoviral Vector
Official Title  ICMJE A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, an Oncolytic Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
Brief Summary To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
Detailed Description

To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.

The Phase Ia part of the study is a dose escalation and dose expansion phase investigating NG-641 administration by intratumorural injection (IT) and intravenous (IV) infusion in a range of tumour types

The Phase Ib part of the study is to investigate safety and efficacy of NG-641 as monotherapy or in combination with chemotherapy agents and/or checkpoint inhibitors in separate efficacy cohorts of patients with specific epithelial tumour types.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Cancer
  • Epithelial Tumor
Intervention  ICMJE Biological: NG-641
NG-641 is an oncolytic adenoviral vector which expresses a FAP-TAc antibody together with an immune enhancer module (CXCL9/CXCL10/IFNα).
Study Arms  ICMJE
  • Experimental: Intratumoural
    In the IT cohort, patients will receive a single dose of NG-641 by IT injection on Day 1. The dose given to each patient will be dependent on the size of the tumour lesion to be injected.
    Intervention: Biological: NG-641
  • Experimental: Intravenous
    In the IV cohort, patients will receive a single cycle of study treatment, with three single doses of NG-641 on Days 1, 3 and 5 by IV infusion.
    Intervention: Biological: NG-641
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2019)
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or cytologically documented advanced or metastatic epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available
  2. Provide written informed consent to participate
  3. Aged 18 years or over
  4. a) For patients undergoing surgical excision/resection of tumour lesion(s):

    • Tumour deemed accessible and safe for biopsy by the Investigator
    • Patient able to undergo surgical procedure and appropriate anaesthesia
    • Willing to consent for baseline biopsies and surgical procedure b) For patients not undergoing surgical excision/resection:
    • Tumour accessible for biopsy and a biopsy deemed safe by the Investigator
    • Willing to consent to tumour biopsies
  5. ECOG performance status 0 or 1
  6. Predicted life expectancy of 3 months or more
  7. Ability to comply with study procedures in the Investigator's opinion
  8. Adequate renal function
  9. Adequate hepatic function
  10. Adequate bone marrow function
  11. Prothrombin time and aPTT time within normal range and international normalised ratio ≤1.5, as appropriate
  12. Meeting reproductive status requirements
  13. Phase Ia - Dose Expansion Phase only: at least one measurable site of disease according to RECIST Version 1.1 criteria

Exclusion Criteria:

  1. Known history or evidence of significant immunodeficiency due to underlying illness
  2. Splenectomy
  3. Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
  4. 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 ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS. Viral serology testing is not required in the absence of history
  5. History of chronic liver disease or evidence of hepatic cirrhosis
  6. History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organising pneumonia (bronchiolitis obliterans, cryptogenic organising pneumonia, etc.)
  7. 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 4 weeks before the first dose of study treatment
  8. Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection
  9. Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding/haemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia
  10. History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment
  11. History of DVT or pulmonary embolus in the 12 months before the first dose of study treatment
  12. History of significant bleeding requiring hospitalisation in the 12 months before the first dose of study treatment
  13. Patients receiving therapeutic or prophylactic anticoagulation therapy
  14. Treatment with PD-1/programmed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 6 weeks before the first dose of study treatment
  15. Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational drug/therapy in the 28 days before the first dose of study treatment
  16. 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
  17. Symptomatic brain metastases or any leptomeningeal metastases that are symptomatic and/or requires treatment. Patients with brain metastases are eligible if these have been treated (surgery, radiotherapy)
  18. Penetrating tumour infiltration of major blood vessels, pericardium, gastrointestinal tract or other hollow organs that may lead to perforation due to tumour necrosis
  19. Patients at an increased risk due to tumour flare, as assessed by the Investigator (e.g. an initial increase in tumour size that may lead to intestinal obstruction, obstruction of the ureter or airway)
  20. Lymphangitic carcinomatosis
  21. Any history of renal disease or renal injury, coagulopathy or autoimmune disease
  22. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, 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
  23. Previous treatment with enadenotucirev or FAP targeting agents
  24. Known allergy to NG-641 transgene products or formulation
  25. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
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 +44 1235835328
Contact: PsiOxus Therapeutics +44 1235426678
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04053283
Other Study ID Numbers  ICMJE NG-641-01
Has Data Monitoring Committee Yes
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
Responsible Party PsiOxus Therapeutics Ltd
Study Sponsor  ICMJE PsiOxus Therapeutics Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haesong Park, MD Washington University School of Medicine, St Louis, Missouri
PRS Account PsiOxus Therapeutics Ltd
Verification Date February 2020

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