Open Actively Recruiting

First in Human Study With NG-641, an Oncolytic Transgene Expressing Adenoviral Vector

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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
  • Provide written informed consent to participate
  • Aged 18 years or over
  • 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
  • ECOG performance status 0 or 1
  • Predicted life expectancy of 3 months or more
  • Ability to comply with study procedures in the Investigator's opinion
  • Adequate renal function
  • Adequate hepatic function
  • Adequate bone marrow function
  • Prothrombin time and aPTT time within normal range and international normalised ratio ≤1.5, as appropriate
  • Meeting reproductive status requirements
  • Phase Ia - Dose Expansion Phase only: at least one measurable site of disease according to RECIST Version 1.1 criteria

Exclusion Criteria:

  • Known history or evidence of significant immunodeficiency due to underlying illness
  • Splenectomy
  • Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
  • 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
  • History of chronic liver disease or evidence of hepatic cirrhosis
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organising pneumonia (bronchiolitis obliterans, cryptogenic organising pneumonia, etc.)
  • 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
  • Incomplete recovery from surgery, incomplete healing of an incision site or evidence of infection
  • 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
  • History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment
  • History of DVT or pulmonary embolus in the 12 months before the first dose of study treatment
  • History of significant bleeding requiring hospitalisation in the 12 months before the first dose of study treatment
  • Patients receiving therapeutic or prophylactic anticoagulation therapy
  • 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
  • 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
  • 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
  • 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)
  • Penetrating tumour infiltration of major blood vessels, pericardium, gastrointestinal tract or other hollow organs that may lead to perforation due to tumour necrosis
  • 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)
  • Lymphangitic carcinomatosis
  • Any history of renal disease or renal injury, coagulopathy or autoimmune disease
  • 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
  • Previous treatment with enadenotucirev or FAP targeting agents
  • Known allergy to NG-641 transgene products or formulation
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Join this Trial

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Study Stats
Protocol No.
21-000275
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04053283
For detailed technical eligibility, visit ClinicalTrials.gov.