CUE-101

DRUG3 trials

Conditions

HPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related CarcinomaHead and Neck CancerHead and Neck Squamous Cell CarcinomaLocally AdvancedNew Diagnosis TumorOropharyngeal Squamous Cell Carcinoma

Phase 1

A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

CompletedNCT03978689

Cue BiopharmaHead and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma

Start: 2019-07-30End: 2026-01-04Updated: 2026-01-22

Phase 2

Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma

RecruitingNCT04852328

Washington University School of MedicineOropharyngeal Squamous Cell Carcinoma

Start: 2021-12-06End: 2027-10-31Target: 30Updated: 2026-07-20

CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs

RecruitingNCT07172256

Yale UniversityHead and Neck Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Locally Advanced +1

Start: 2026-05-07End: 2031-02-01Target: 30Updated: 2026-07-30

Journal of Clinical Oncology2025-05-281 citations

Characterization of dynamic changes in tumor-infiltrating lymphocytes (TIL) after neoadjuvant administration of CUE-101, an HPV16 E7-HLA-IL2 fusion protein, to patients with HPV+ locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC).

Journal of Clinical Oncology2025-05-28

A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).

Journal of Clinical Oncology2024-06-0113 citations

674 A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic HPV16+ head and neck cancer patients

Regular and Young Investigator Award Abstracts2023-10-31

A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer.

Journal of Clinical Oncology2023-06-0110 citations

Phase 2 trial of three schedules of CUE-101 administered before surgery or chemoradiotherapy in HLA-A*0201 positive patients with HPV16+ OPSCC.

Journal of Clinical Oncology2023-06-011 citations

Abstract 3365: Circulating free HPV16 DNA as a potential biomarker for immunotherapy-based trials in HPV16+ head and neck squamous cell carcinoma

Cancer Research2023-04-04

681 A phase 1 study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer

Regular and Young Investigator Award Abstracts2022-11-013 citations

A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer.

Journal of Clinical Oncology2022-06-0110 citations

Treating Recurrent/Metastatic HPV+ Head & Neck Squamous Cell Carcinoma

Oncology Times2022-05-20

438 A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer

Regular and Young Investigator Award Abstracts2021-11-012 citations

354 A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer

Regular and Young Investigator Award Abstracts2020-11-013 citations

CUE-101, a Novel E7-pHLA-IL2-Fc Fusion Protein, Enhances Tumor Antigen-Specific T-Cell Activation for the Treatment of HPV16-Driven Malignancies

Clinical Cancer Research2020-01-2155 citations

CUE-101

Sponsors

Conditions

Phase 1

Phase 2

Related Papers