649 A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer
Chung C, Dimitrios Colevas A, 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, Agensky L, Goel A, Levisetti M, Margossian S, Quayle S, Pai S. 649 A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer. 2024, a745-a745. DOI: 10.1136/jitc-2024-sitc2024.0649.Peer-Reviewed Original ResearchHead and neck squamous cell cancerPhase 1 dose-escalationSquamous cell cancerCell cancerPembrolizumabMonotherapyPatientsCancerHERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors.
Bhatia A, Hayashi H, Kogawa T, Nishina T, Fountzilas C, Castillo D, McKean M, Colombo N, Smithy J, Fayette J, Chandra S, Powles T, Kudchadkar R, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Burtness B. HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps3164-tps3164. DOI: 10.1200/jco.2024.42.16_suppl.tps3164.Peer-Reviewed Original ResearchHead and neck squamous cell cancerHuman epidermal growth factor receptor 3Platinum-based chemotherapyHER3-DXdPhase 2 trialAntibody-drug conjugatesSolid tumorsHuman anti-HER3 monoclonal antibodyAnti-HER3 monoclonal antibodyAnti-PD-(L)1 therapyGastric cancerHER2-negative gastric cancerTopoisomerase I inhibitor payloadAssociated with poor clinical outcomesEpidermal growth factor receptor 3Anti-HER3 antibodiesGastroesophageal junction cancerHER2+ cancersMetastatic solid tumorsMetastatic breast cancerSquamous cell cancerBRAF wild-typePoor clinical outcomesMultiple tumor typesAcral subtypeA 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