protocolSection identificationModule nctId: NCT06378177, orgStudyIdInfo id: LVGN6051-0402-HNSCC, briefTitle: A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Lyvgen Biopharma Holdings Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This is a multicenter, open-labeled, single-arm Phase 2 clinical study.This study comprises two parts. Part 1 (Safety Run-in Phase) is designed to confirm the dose of combination therapy in Part 2., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: LVGN6051 Monoclonal Antibody Injection, interventions name: toripalimab Injection, interventions name: Paclitaxel injection, outcomesModule primaryOutcomes measure: to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ), primaryOutcomes measure: to determine objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Cancer Hospital, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Jin Gao, role: CONTACT, phone: +86 15395005376, email: gj11667@126.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yan Sun, role: CONTACT, phone: +86 13671370026, email: 13671370026@139.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tongren Hospital Affiliated to Capital Medical University, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Shurong Zhang, role: CONTACT, phone: +86 13501085646, email: 13501085646@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fujian cancer hospital, city: Fuzhou, state: Fujian, zip: 350014, country: China, contacts name: Sufang Qiu, role: CONTACT, phone: +86 13609589163, email: sfqiu@126.com, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Xiaoming Huang, role: CONTACT, phone: +86 13602808820, email: xiaoming.huang@126.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: Guangxi Medical University Cancer Hospital, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Song Qu, role: CONTACT, phone: +86 13607887386, email: 13607887386@163.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Henan cancer hospital, city: Zhengzhou, state: Henan, zip: 450008, country: China, contacts name: Hui Wu, role: CONTACT, phone: +86 13503716710, email: wuhui7008@126.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Kunyu Yang, role: CONTACT, phone: +86 13995595360, email: yangky71@aliyun.com, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Guangyuan Hu, role: CONTACT, phone: +86 13886000095, email: h.g.y.121@163.com, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Liangfang Shen, role: CONTACT, phone: +86 13975805137, email: slf1688@sina.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Second Xiangya Hospital, Central South University, city: Changsha, state: Hunan, zip: 410011, country: China, contacts name: Ping Liu, role: CONTACT, phone: +86 15084987287, email: cyril0820@sina.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Yaqian Han, role: CONTACT, phone: +86 18673176667, email: hanyaqiancs@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410031, country: China, contacts name: Jinguan Lin, role: CONTACT, phone: +86 13307318568, email: xjl5027@easthospital.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Liaoning cancer hospital, city: Shenyang, state: Liaoning, zip: 110042, country: China, contacts name: Xia Li, role: CONTACT, phone: +86 189 0091 7377, email: lixiadoctor@163.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shanghai Oriental Hospital, city: Shanghai, state: Shanghai, zip: 200123, country: China, contacts name: Ye Guo, role: CONTACT, phone: +86 13501678472, email: pattrickguo@gmail.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Lei Liu, role: CONTACT, phone: +86 18980606231, email: 32498600@qq.com, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Meiyu Fang, role: CONTACT, phone: +86 13750851650, email: fangmy@zjcc.org.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False