An Open-label, Phase I/Proof of Principle, Dose Escalation Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation (PCI) of Antigen/Adjuvant in Healthy Male/Female Subjects

Trial Profile

An Open-label, Phase I/Proof of Principle, Dose Escalation Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation (PCI) of Antigen/Adjuvant in Healthy Male/Female Subjects

Recruiting
Phase of Trial: Phase I

Latest Information Update: 28 Nov 2017

At a glance

  • Drugs Fimaporfin (Primary) ; Human papillomavirus E7 protein modulators; Keyhole limpet haemocyanin; Poly ICLC
  • Indications Cholangiocarcinoma; Malignant melanoma
  • Focus Adverse reactions; Proof of concept
  • Sponsors PCI Biotech
  • Most Recent Events

    • 28 Nov 2017 According to a PCI Biotech media release, further expansion of the Phase I study is therefore planned to investigate even lower doses.
    • 12 Oct 2017 According to a PCI Biotech media release, company has announced first immune response results from this study.The clinical data cover more than 50% of the planned subjects in the ongoing dose finding part of the study. The dose finding will continue to establish maximum tolerated dose and further explore the efficacy of fimaVACC. The study remains on track for completion by first half of 2018.
    • 09 Sep 2017 Results presented at the 3rd CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference
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