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Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

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Paclitaxel

Albumin-Bound Paclitaxel

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LVGN6051 in combination with toripalimab and paclitaxel

LVGN6051 Monoclonal Antibody Injection:1 mg/kg or 2 mg/kg, every 3 weeks(Q3W) , on the first day of the treatment cycle for up to 2 years.

LVGN6051 Monoclonal Antibody Injection

toripalimab Injection: 240mg fixed dose,Q3W, on the first day of the treatment cycle for up to 2 years.

toripalimab Injection

paclitaxel Injection:5ml:100 mg/m2(80 mg/m2 or 60 mg/m2 can be used if necessary),Q3W,on the first and eighth day of the treatment cycle for up to 2 years

Paclitaxel injection

Yan Wang

Jin Gao

Yan Sun

Shurong Zhang

Sufang Qiu

Xiaoming Huang

Song Qu

Hui Wu

Kunyu Yang

Guangyuan Hu

Liangfang Shen

Ping Liu

Yaqian Han

Jinguan Lin

Xia Li

Ye Guo

Lei Liu

Meiyu Fang

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.

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.

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.

A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)

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

The safety and tolerability of two preset dose levels based on treatment-related adverse events (TRAEs), including dose-limiting toxicities(DLTs )and serious adverse events (SAEs), through a "safety run-in" to determine the Part 2 therapeutic dose of LVGN6051 in combination with toripalimab and paclitaxel. (Part 1)

The anti-tumor activity of LVGN6051 combined with toripalimab and paclitaxel will be evaluated by independent central review (ICR) according to RECIST 1.1 for objective response rate (ORR). (Part 2)

Lyvgen Biopharma Holdings Limited

Spots Global Cancer Trial Database for lvgn6051 monoclonal antibody injection