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An open-label, multicenter, Phase I/IIa study assessing the safety and efficacy of EGFR targeted EDVsTM carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate (EGFR EDV-D682/GC Trial)

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Trial Profile

An open-label, multicenter, Phase I/IIa study assessing the safety and efficacy of EGFR targeted EDVsTM carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate (EGFR EDV-D682/GC Trial)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 May 2025

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At a glance

  • Drugs EGFR-VEDVsPNU+EDVs40 mer (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Colorectal cancer; Head and neck cancer; Malignant melanoma; Mesothelioma; Neuroendocrine tumours; Non-small cell lung cancer; Pancreatic cancer; Renal cancer; Triple negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ENG19
  • Sponsors EnGeneIC

Most Recent Events

  • 20 May 2025 New source identified and integrated (Australian New Zealand Clinical Trials Registry: ACTRN12625000203459).
  • 20 May 2025 New trial record
  • 12 May 2025 According to an EnGeneIC media release, first patient has been dosed in Phase I/IIa basket trial for solid tumours at Mater Hospital, North Sydney

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