2024
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).
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Worden F, Johnson F, Saba N, Burtness B, Julian R, Bauman J, Jotte R, Seiwert T, Dunn L, Chaney M, Margossian S, Levisetti M, Pai S. 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 Oncology 2024, 42: 6004-6004. DOI: 10.1200/jco.2024.42.16_suppl.6004.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsMedian OSCheckpoint inhibitorsHLA-A*0201Adverse eventsInterleukin-2Combined cohortHead and neck squamous cell cancerE7-specific T cellsPhase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8First-in-human studyTargeted delivery of cytokinesHLA-A*0201 patientsPhase 2 doseDisease control rateGrade 3 AEsInfusion-related reactionsT-cell engagersSquamous cell cancerDelivery of cytokines
2022
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.
Chung C, Colevas A, Adkins D, Gibson M, Rodriguez C, Sukari A, Bauman J, Wirth L, Johnson F, Saba N, Burtness B, Dunn L, Seiwert T, Worden F, Muzaffar J, Margossian S, Moniz R, Quayle S, Levisetti M, Pai S. 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 Oncology 2022, 40: 6045-6045. DOI: 10.1200/jco.2022.40.16_suppl.6045.Peer-Reviewed Original ResearchCD8+ T cellsHuman leukocyte antigenT cellsInterleukin-2R/M HNSCCHLA-A*0201Recurrent/metastatic head and neck squamous cell carcinomaTumor antigen-specific T cellsHead and neck squamous cell carcinomaDelivery of interleukin-2Phase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8Neck squamous cell carcinomaFirst-in-human studyAntitumor activityDose-escalation cohortsHLA-A*0201 patientsPhase 2 doseTumor-specific CD8Data cut-offSpecific T cellsFirst-line treatmentSquamous cell carcinomaDose-dependent increase
2021
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
Chung C, Colevas A, Gibson M, Adkins D, Sukari A, Wirth L, Burtness B, Bauman J, Rodriguez C, Worden F, Saba N, Glisson B, Dunn L, Seiwert T, Agensky L, Levisetti M, Lynam R, Margossian S, Moniz R, Quayle S, Pienta K, Pai S. 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. Journal For ImmunoTherapy Of Cancer 2021, 9: a468-a468. DOI: 10.1136/jitc-2021-sitc2021.438.Peer-Reviewed Original ResearchTreatment of HPV16Institutional review boardT cellsCombination cohortInterleukin-2HPV16 E7-specific CD8HPV16-specific T cellsPD-L1 tumor expressionRecurrent/metastatic headTumor-specific T cellsNeck squamous cell carcinomaAntigen-specific T cell activationSpecific T cell activationCTCAE grade 2Ongoing partial responsePhase 2 doseRECIST 1.1 criteriaAntitumor activityE7-specific CD8First-line treatmentAnti-tumor immunityPost-treatment biopsiesNatural killer cellsPhase 1 trialSquamous cell carcinoma