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A Phase I Open-label Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax in Patients With Progressing Gastrointestinal Stromal Tumors (GIST) During Ongoing Second, Third or Fourth Line Treatment With Tyrosine Kinase Inhibition Therapy. A Prospective Single Armed, Open Label Phase I Safety and Efficacy Study

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A Phase I Open-label Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax in Patients With Progressing Gastrointestinal Stromal Tumors (GIST) During Ongoing Second, Third or Fourth Line Treatment With Tyrosine Kinase Inhibition Therapy. A Prospective Single Armed, Open Label Phase I Safety and Efficacy Study

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Oct 2022

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At a glance

  • Drugs Ilixadencel (Primary) ; Regorafenib; Sunitinib
  • Indications Gastrointestinal stromal tumours
  • Focus Adverse reactions
  • Sponsors Mendus

    • Most Recent Events

    • 19 Feb 2021 According to an Immunicum AB media release, the company received Orphan Drug Designation from EMA for Ilixadencel. The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the company's application for orphan designation status for ilixadencel, for the treatment of Gastrointestinal Stromal Tumors (GIST). The COMP opinion was based on results from this study.
    • 26 Jan 2021 According to an Immunicum AB media release, it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for ilixadencel, a cell-based, off the shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS). The designation recognizes results from this trial.
    • 07 Dec 2020 According to an Immunicum AB media release, it has received Fast Track Designation from the U.S. Food and Drug Administration for the Company,s lead candidate based on results from this trial.

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