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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Cancer Epithelial Tumor | Biological: NG-350A | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Intratumoural (Cohort 1)
Patients will receive a single dose of NG-350A by IT injection.
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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. |
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provide written informed consent to participate
- Aged 18 years or over
- 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
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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
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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
Exclusion Criteria:
- Known history or evidence of significant immunodeficiency due to underlying illness.
- Splenectomy
- Prior allogeneic or autologous bone marrow or organ transplantation
- 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 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
- 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
- Administration of an investigational drug in the 28 days, or six half-lives (whichever is longer) before the first dose of study treatment
- 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.
- 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 metastasis that is symptomatic and/or requires treatment. Patients with brain metastases are eligible if these have been locally treated (surgery, radiotherapy).
- Any history of renal disease or renal injury or autoimmune disease.
- 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
- History of myocardial infarction or significant cardiovascular or cerebrovascular event in the 12 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
- Previous treatment with enadenotucirev or an anti-CD40 antibody
- Known allergy to NG-350A transgene products or formulation
- Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- Patients at an increased risk due to tumour flare
- Clinically suspected or radiographic evidence of lymphangitic carcinomatosis
- History of idiopathic pulmonary fibrosis, pneumonitis, organising pneumonia, or evidence of active pneumonitis
- Dependence on supplemental oxygen use
- Treatment with any immune checkpoint inhibitors or immune-stimulatory treatment in the 6 weeks before the first dose of study treatment
- Penetrating tumour infiltration of major blood vessels, pericardium, gastrointestinal tract or other hollow organs that may lead to perforation due to tumour necrosis

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
Contact: PsiOxus Therapeutics | +44 1235835328 | enquiries@psioxus.com |
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 |
Principal Investigator: | Aung Naing, MD | The University of Texas MD Anderson Cancer Center |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
metastatic; epithelial; virus; advanced |
Neoplasm Metastasis Neoplasms, Glandular and Epithelial Neoplastic Processes |
Neoplasms Pathologic Processes Neoplasms by Histologic Type |