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An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma

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Trial Profile

An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 30 Dec 2024

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At a glance

  • Drugs AIV 001 (Primary) ; AIV 001 (Primary)
  • Indications Basal cell cancer; Carcinoma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors AiViva BioPharma
  • Most Recent Events

    • 09 Dec 2024 According to AiViva Biopharma media release, company announced the receipt of FDA clearance for testing AIV001 (axitinib) by intradermal injection with their formulation in facial skin. This FDA clearance was supported by AiViva submission of safety data on non-facial skin tolerability and efficacy, and systemic exposure from 67 subjects treated with AIV001 in BCC and in scar management.
    • 11 Dec 2023 Status changed from active, no longer recruiting to completed, according to a AiViva Biopharma media release.
    • 11 Apr 2023 Planned End Date changed from 10 Mar 2023 to 23 Jun 2023.

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