nctId: NCT06378177 id: LVGN6051-0402-HNSCC briefTitle: A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-10-31 date: 2027-10-31 date: 2024-04-22 date: 2024-04-26 name: Lyvgen Biopharma Holdings Limited class: INDUSTRY 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. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 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 masking: NONE count: 64 type: ESTIMATED name: LVGN6051 Monoclonal Antibody Injection name: toripalimab Injection name: Paclitaxel injection measure: to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ) measure: to determine objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Cancer Hospital city: Hefei state: Anhui zip: 230000 country: China name: Jin Gao role: CONTACT phone: +86 15395005376 email: gj11667@126.com lat: 31.86389 lon: 117.28083 facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yan Sun role: CONTACT phone: +86 13671370026 email: 13671370026@139.com lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital Affiliated to Capital Medical University city: Beijing state: Beijing zip: 100730 country: China name: Shurong Zhang role: CONTACT phone: +86 13501085646 email: 13501085646@163.com lat: 39.9075 lon: 116.39723 facility: Fujian cancer hospital city: Fuzhou state: Fujian zip: 350014 country: China name: Sufang Qiu role: CONTACT phone: +86 13609589163 email: sfqiu@126.com lat: 26.06139 lon: 119.30611 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510120 country: China name: Xiaoming Huang role: CONTACT phone: +86 13602808820 email: xiaoming.huang@126.com lat: 23.11667 lon: 113.25 facility: Guangxi Medical University Cancer Hospital city: Nanning state: Guangxi zip: 530021 country: China name: Song Qu role: CONTACT phone: +86 13607887386 email: 13607887386@163.com lat: 22.81667 lon: 108.31667 facility: Henan cancer hospital city: Zhengzhou state: Henan zip: 450008 country: China name: Hui Wu role: CONTACT phone: +86 13503716710 email: wuhui7008@126.com lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430000 country: China name: Kunyu Yang role: CONTACT phone: +86 13995595360 email: yangky71@aliyun.com lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Guangyuan Hu role: CONTACT phone: +86 13886000095 email: h.g.y.121@163.com lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Liangfang Shen role: CONTACT phone: +86 13975805137 email: slf1688@sina.com lat: 28.19874 lon: 112.97087 facility: The Second Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410011 country: China name: Ping Liu role: CONTACT phone: +86 15084987287 email: cyril0820@sina.com lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Yaqian Han role: CONTACT phone: +86 18673176667 email: hanyaqiancs@163.com lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Jinguan Lin role: CONTACT phone: +86 13307318568 email: xjl5027@easthospital.com lat: 28.19874 lon: 112.97087 facility: Liaoning cancer hospital city: Shenyang state: Liaoning zip: 110042 country: China name: Xia Li role: CONTACT phone: +86 189 0091 7377 email: lixiadoctor@163.com lat: 41.79222 lon: 123.43278 facility: Shanghai Oriental Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Ye Guo role: CONTACT phone: +86 13501678472 email: pattrickguo@gmail.com lat: 31.22222 lon: 121.45806 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Lei Liu role: CONTACT phone: +86 18980606231 email: 32498600@qq.com lat: 30.66667 lon: 104.06667 facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310022 country: China name: Meiyu Fang role: CONTACT phone: +86 13750851650 email: fangmy@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False