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First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector (STAR)

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 : January 18, 2023
Information provided by (Responsible Party):
Akamis Bio

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

Condition or disease Intervention/treatment Phase
Metastatic Cancer Epithelial Tumor Biological: NG-641 Phase 1

Detailed Description:

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

The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types.

The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: N/A
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-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
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.
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).

Primary Outcome Measures :
  1. Incidence of adverse events (safety and tolerability) in study NG-641 [ Time Frame: End of study treatment visit ]
    Incidence of adverse events, adverse events meeting protocol-defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  • 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
  • Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
  • ECOG performance status 0 or 1
  • Predicted life expectancy of 6 months or more
  • Ability to comply with study procedures in the Investigator's opinion
  • Adequate lung reserve
  • Adequate renal function
  • Adequate hepatic function
  • Adequate bone marrow function
  • Coagulation profile within normal range and International Normalised Ratio ≤1.5, as appropriate
  • Meeting reproductive status requirements
  • Phase Ia - Dose Optimisation Phase only: at least one measurable site of disease according to RECIST Version 1.1 criteria

Exclusion Criteria:

  • Prior or planned allogenic or autologous bone marrow or organ transplantation
  • Splenectomy
  • Active infection within 1 week of the anticipated first dose of study drug that required antibiotics (or other systemic therapy), physician monitoring or was associated with recurrent fevers (>38.0˚C)
  • 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
  • Patients who have active autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving systemic immunosuppressive treatment
  • Treatment with any live, live-attenuated or COVID-19 vaccine in the 28 days before the first dose of NG-641
  • Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before the first dose of NG-641
  • History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
  • History of clinically significant interstitial lung disease or non-infectious pneumonitis
  • Lymphangitic carcinomatosis
  • Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
  • All toxicities attributed to prior anti-cancer therapy (including radiation therapy) other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment
  • Tumour location/extent considered by the Investigator to present a significant risk if tumour flare or necrosis were to occur
  • 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
  • Grade 3 or 4 gastrointestinal bleeding
  • Pulmonary embolism, deep vein thrombosis, or other uncontrolled thromboembolic event in the 12 months before the first dose of study treatment
  • Myocardial infarction, stroke or other significant cardiovascular or cerebrovascular event in the 12 months before the first dose of study treatment
  • Treatment with an investigational or licensed anti-cancer monoclonal antibody (mAb), immune checkpoint inhibitor, immune stimulatory treatment or other biological therapy in the 28 days prior to the first dose of study treatment.
  • Major surgery in the 28 days before the first dose of study treatment or radiation therapy in the 14 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)
  • 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

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 identifier (NCT number): NCT04053283

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Contact: Akamis Bio +44 1235835328
Contact: Akamis Bio +44 1235426678

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United States, California
University of Southern California (USC) - Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Gloria Bryant    323-865-3967   
Principal Investigator: Heinz-Josef Lenz         
UCLA Recruiting
Santa Barbara, California, United States, 93105
Contact: Rose Estrada   
Principal Investigator: Lee Rosen         
United States, Florida
Moffitt-Advent Health Clinical Research Unit Recruiting
Celebration, Florida, United States, 34747
Contact: Felipe Valerio    321-460-3580   
Principal Investigator: George Simon         
United States, Louisiana
Ochsner Medical Center (OMC) - The Gayle and Tom Benson Cancer Center Completed
New Orleans, Louisiana, United States, 70121-2429
United States, Missouri
Washington University Medical School Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Texas
MD Anderson Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Akamis Bio
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Responsible Party: Akamis Bio Identifier: NCT04053283    
Other Study ID Numbers: NG-641-01
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

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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 Akamis Bio:
metastatic; epithelial; virus; advanced; PsiOxus
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Neoplasms by Histologic Type