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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: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 14 May 2025

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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

  • 08 May 2025 According to a Cue Biopharma media release, company will discuss data from this study at a company hosted virtual investor event on Thursday, May 15, 2025 at 11:00 AM ET. To register.
  • 11 Mar 2025 Planned End Date changed from 1 May 2025 to 1 Jan 2026.
  • 11 Mar 2025 Planned primary completion date changed from 1 Nov 2024 to 1 Jan 2026.

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