First Patient Dosed in Expansion of Phase 1 Clinical Trial for Squamous Cell Carcinoma


The first patient with HPV-positive head and neck squamous cell carcinoma received their dose of in the CUE-101 phase 1b trial.

The first patient received their dose in the CUE-101 phase 1 monotherapy clinical trial for patients with HPV-positive second line and beyond head and neck squamous cell carcinoma (HNSCC) in June of this year, as part of a part b expansion.

The patient was dosed at 4mg/kg, which is the recommended phase 2 dose. Cue Biopharma, Inc. expects to enroll up to 20 patients in this portion of the trial.

“We believe the data supporting the selection of the cohort 6 dose at 4mg/kg to confirm a recommended phase 2 dose gives us growing confidence that CUE-101 may provide a potential path forward for a registration-directed clinical trial as a single agent treatment for HPV+ 2L+ HNSCC,” said Dr. Ken Pienta, acting chief medical officer of Cue Biopharma, in a press release.

The data that lead to the phase b expansion was encouraging, according to the release. Six patients had stable disease while one had a confirmed partial response of 50% tumor reduction after dose escalation. The trial is the first-in-human to evaluate the safety, anti-tumor effect and immunogenicity of the drug.

Cue Biopharma has also expanded the study to evaluate CUE-101 in combination with Keytruda (pembrolizumab) as a first-line treatment for patients with HPV16-driven recurrent or metastatic HNSCC.

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