An open labelled first human dose phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head and neck, who did not reach complete responses with current standard of care immune checkpoint blockade

Trial Profile

An open labelled first human dose phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head and neck, who did not reach complete responses with current standard of care immune checkpoint blockade

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Jan 2018

At a glance

  • Drugs VB10-NEO (Primary)
  • Indications Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Renal cancer; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Sponsors Vaccibody
  • Most Recent Events

    • 24 Jan 2018 According to a Vaccibody media release, a total of 40 patients are planned to be enrolled in the phase I part of the trial.
    • 24 Jan 2018 According to a Vaccibody media release, the company announces conditional approval of Clinical Trial Application (CTA) for this trial also the Company estimates that remaining conditions, which relates to securing and documenting certain aspects of the quality of the vaccine to be used, will be met to allow for final approval of the CTA in Q1, 2018 in line with previously communicated timelines.
    • 19 Jan 2018 Status changed from planning to recruiting.
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