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A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC

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Trial Profile

A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Jan 2026

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At a glance

  • Drugs CUE 101 (Primary) ; Pembrolizumab (Primary)
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Acronyms KEYNOTE' KN-A78; KEYNOTE-A78
  • Sponsors Cue Biopharma

Most Recent Events

  • 22 Jan 2026 Status changed from active, no longer recruiting to completed.
  • 16 Jul 2025 Results presented in the Cue Biopharma Media Release.
  • 01 Jul 2025 Results presented in a Cue Biopharma media release.

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