drugset / Trial / NCT06378177

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

NCT06378177

Phase 2 Active not recruiting 64 enrolled Lyvgen Biopharma Holdings Limited
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2024-06-21
Primary completion
2027-10-31
Completion
2027-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject EXLINKIBART Monoclonal antibody 1 mg/kg
Subject EXLINKIBART Monoclonal antibody 2 mg/kg
Subject Paclitaxel Small molecule 60 mg/m2
Subject Paclitaxel Small molecule 80 mg/m2
Subject Paclitaxel Small molecule 100 mg/m2
Subject Toripalimab Monoclonal antibody 240 mg