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A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intra-tumorally in Patients With Hepatocellular Carcinoma

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Trial Profile

A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intra-tumorally in Patients With Hepatocellular Carcinoma

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 03 Jan 2023

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At a glance

  • Drugs Ilixadencel (Primary) ; Sorafenib
  • Indications Cholangiocarcinoma; Liver cancer
  • Focus Adverse reactions
  • Sponsors Immunicum; Mendus

    • Most Recent Events

    • 01 Jan 2023 Results (n=17) assessing the response to intratumoral injections with the immune primer ilixadencel in HCCs with diffusion weighted magnetic resonance imaging using intravoxel incoherent motion and histogram analysis published in the Acta Radiologica
    • 31 Dec 2020 According to an Immunicum media release, the company announced that it has received Orphan Drug Designation(ODD) from the U.S. Food and Drug Administration(FDA) for Ilixadencel for the treatment of Hepatocellular Carcinoma(HCC). The designation was based on data from this Phase I/II clinical trial of ilixadencel in patients with unresectable and/or metastatic HCC.
    • 21 Jan 2019 According to an Immunicum media release, final data analysis from this exploratory clinical study has been published in the journal, Frontiers in Oncology.

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