A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
This study tests a new combination treatment for head and neck cancer that has come back or spread after previous treatment. The combination includes LVGN6051 (a type of immunotherapy that activates the immune system), toripalimab (another immunotherapy), and paclitaxel (a chemotherapy drug).
Key Objective:The trial is testing whether combining these three drugs can shrink tumors and improve survival in patients whose cancer has progressed despite previous treatment.
Who to Consider:Patients with recurrent or metastatic head and neck squamous cell carcinoma whose cancer has progressed rapidly after prior treatment should consider enrolling.
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: 1. Age of 18 years or older on the date of signing the informed consent. 2. Understand and be willing to sign a written informed consent. 3. Patients with recurrent/metastatic head and neck squamous cell carcinoma confirmed by histology or cytology (the primary tumor is located in the oral cavity, oropharynx, hypopharynx, or larynx) that cannot be resected and cannot be cured by local treatment. 4. The status of head and neck squamous cell carcinoma meets one of the following requirements: a. There is still residual tumor, local recurrence, or metastatic cancer within 6 months after platinum-containing neoadjuvant treatment, adjuvant treatment, or curative concurrent chemoradiotherapy, or b. Any residual tumor, local recurrence, or metastatic cancer should receive first-line systemic therapy, but this first-line systemic therapy is not suitable for platinum-containing regimens. 5. Have measurable lesions as defined by the RECIST 1.1. 6. ECOG PS 0 or 1. 7. Life expec