Spots Global Cancer Trial Database for A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
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Trial Identification
Brief Title: A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
Official Title: A Phase 2 Study of LVGN6051 Combined With Toripalimab and Paclitaxel for Recurrent/Metastatic HNSCC Rapidly Progressed From Previous Platinum-containing Curative Treatment or Contraindicated for Platinum-containing Treatment
Study ID: NCT06378177
Conditions
Study Description
Brief Summary: 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.
Detailed Description: This is a multicenter, open-labeled, single-arm Phase 2 clinical study to evaluate the safety and efficacy of LVGN6051 in combination with toripalimab and paclitaxel in selected patients with recurrent/metastatic head and neck squamous cell carcinoma under the guidance of Good Clinical Practise(GCP). This study comprises two parts. Part 1 (Safety run-in Phase) is designed to confirm the dose of combination therapy in Part 2. Part 1 includes a "3+3 dose-escalation design" for 2 dose levels, i.e., LVGN6051 1 mg/kg or LVGN6051 2 mg/kg with standard doses of toripalimab and paclitaxel (every 3 weeks for a treatment cycle). Part 1 will treat up to 12 DLT-evaluable patients, and the Data monitoring committee(DMC), based on the safety profile, will confirm the recommended dose for combination therapy in Part 2. Part 2 (Efficacy Exploration Phase) will treat up to 52 patients with evaluable tumor response (efficacy) using the recommended dose of combination therapy determined in Part 1. The sample size for Part 2 is based on Simon's two-stage minimax design, which uses the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) objective response rate (ORR) as the primary efficacy endpoint. The first stage will include 28 patients with evaluable tumor response (efficacy). If 6 or more responses are observed, the second stage 2 will consist of an additional 24 patients with evaluable tumor response. Part 1 patients with the same dose level as Part 2, if they meet evaluable tumor response, can be included in the required 52 patients with evaluable tumor response.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Cancer Hospital, Hefei, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, Beijing, China
Fujian cancer hospital, Fuzhou, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China
Henan cancer hospital, Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The Second Xiangya Hospital, Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Liaoning cancer hospital, Shenyang, Liaoning, China
Shanghai Oriental Hospital, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Ye Guo
Affiliation: Shanghai Oriental Hospital
Role: PRINCIPAL_INVESTIGATOR
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