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A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours

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Trial Profile

A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2024

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At a glance

  • Drugs NG 350A (Primary) ; NG 350A (Primary) ; Pembrolizumab (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Carcinoma; Cervical cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; Liver cancer; Non-small cell lung cancer; Oesophageal cancer; Oropharyngeal cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer; Uterine cancer
  • Focus Adverse reactions; First in man
  • Acronyms FORTITUDE
  • Sponsors Akamis Bio; PsiOxus Therapeutics

    • Most Recent Events

    • 23 Oct 2024 According to an Akamis Bio media release, proof-of-mechanism data from this study, supporting the continued clinical development and intravenous route of administration of NG-350A, has been published in the Journal for ImmunoTherapy of Cancer (JITC), showing strong evidence of Tumor Delivery, Viral Replication and Transgene Expression.
    • 28 Feb 2024 Results assessing tolerability, persistence and pharmacodynamic (PD) profile of IV-administered next-generation adenoviral vectors supports clinical expansion in solid cancers presented at the ESMO Targeted Anticancer Therapies Congress 2024
    • 06 Jun 2023 Results presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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