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Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap (M7824) in Subjects With HPV Positive Cancers

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Trial Profile

Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap (M7824) in Subjects With HPV Positive Cancers

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 Apr 2025

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At a glance

  • Drugs Bintrafusp alfa (Primary) ; PRGN-2009 (Primary)
  • Indications Anal cancer; Cervical cancer; Head and neck cancer; Lung cancer; Oesophageal cancer; Oropharyngeal cancer; Penile cancer; Rectal cancer; Solid tumours; Squamous cell cancer; Vulvovaginal cancer
  • Focus Adverse reactions; First in man; Therapeutic Use

Most Recent Events

  • 21 Mar 2025 Results (n=17, data cut-off: 10 Nov 2023) assessing safety, immunogenecity and clinical activity of PRGN-2009 as a monotherapy, and in combination with Bintrafusp alfa, published in the Cancer Immunology Immunotherapy.
  • 06 Aug 2024 According to Precigen media release, Company plans to continue PRGN-2009 Phase 2 trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer.
  • 20 Nov 2023 Planned End Date changed from 1 Oct 2023 to 20 Nov 2025.

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