Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

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.

Official Title

A Multicentre, Open-label, Non Randomised First in Human Study of NG-350A in Patients With Metastatic or Advanced Epithelial Tumours

Details

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.

Keywords

Metastatic Cancer Epithelial Tumor metastatic; epithelial; virus; advanced Neoplasm Metastasis Neoplasms, Glandular and Epithelial Antibodies Intravenous

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  5. Tumour deemed accessible and safe for biopsy by the Investigator
  6. Willing to consent to biopsies and surgical procedure
  7. 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
  • Safety expansion and efficacy cohorts only: at least one measurable site of disease according to RECIST criteria.
  • Eastern Cooperative Oncology Group (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
  • Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
  • . Adequate lung reserve
  • . Adequate renal function
  • . Adequate hepatic function
  • . Adequate bone marrow function
  • . Prothrombin time and aPTT within normal range or international normalised ratio ≤1.5, as appropriate
  • . Meeting the reproductive requirements of the study

You CAN'T join if...

  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

Locations

  • University of California, Los Angeles (UCLA) accepting new patients
    Santa Monica California 90404 United States
  • University of Colorado accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PsiOxus Therapeutics Ltd
ID
NCT03852511
Phase
Phase 1
Study Type
Interventional
Last Updated