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A Phase 1/2 Open Label Study of LabVax 3(22)-23 and Adjuvant GM-CSF Alone or in Combination With Pembrolizumab in Subjects With Labyrinthin-Positive Adenocarcinomas

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Trial Profile

A Phase 1/2 Open Label Study of LabVax 3(22)-23 and Adjuvant GM-CSF Alone or in Combination With Pembrolizumab in Subjects With Labyrinthin-Positive Adenocarcinomas

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 May 2024

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At a glance

  • Drugs Labvax-LabyRx Immunologic Therapeutics (Primary) ; Pembrolizumab (Primary) ; Sargramostim (Primary)
  • Indications Adenocarcinoma; Brain metastases; Colon cancer; Non-small cell lung cancer; Ovarian cancer; Rectal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use

    • Most Recent Events

    • 10 Oct 2023 Planned number of patients changed from 10 to 77, Interventional study model has been changed to Sequential, Number of treatment arms has been changed to 2, Primary endpoint has been amended and trial focus has now shifted to Ar and Tu, this trial is now a Phase 1/2 study.
    • 10 Oct 2023 Planned End Date changed from 20 Sep 2027 to 1 Jan 2030.
    • 10 Oct 2023 Planned primary completion date changed from 20 Sep 2023 to 1 Jan 2026.

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