OncoMatch/Clinical Trials/NCT06378177
A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
Is NCT06378177 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including LVGN6051 Monoclonal Antibody and toripalimab for head and neck squamous cell carcinoma.
Treatment: LVGN6051 Monoclonal Antibody · toripalimab · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: CD137-targeted therapy
Have received drug treatment targeting CD137 (4-1BB)
Cannot have received: taxane (paclitaxel)
Have received ... paclitaxel injection
Cannot have received: systemic anti-tumor treatment
Exception: after disease recurrence or metastasis
Have received any systemic anti-tumor treatment after disease recurrence or metastasis
Lab requirements
Blood counts
Hb ≥9.0 g/dL; ANC ≥1500/μL; Platelet count ≥100,000/μL
Kidney function
CCR ≥30 ml/min
Liver function
Total bilirubin ≤ ULN; AST ≤1.5× ULN and ALT ≤1.5× ULN
Cardiac function
No acute myocardial infarction within 6 months before Cycle 1 Day 1, no congestive heart failure as Class III or IV by NYHA, no unstable angina, uncontrolled arrhythmias requiring further treatment, stroke, or brain hemorrhage
The functions of important organs within 1 week before the first dose meet all the following requirements: a. Hb ≥9.0 g/dL (90 g/L), b. ANC ≥1500/μL (1.5×109/L), c. Platelet count (PLT) ≥100,000/μL (100×109/L), d. Total bilirubin ≤ upper limit of normal laboratory value (ULN), e. AST ≤1.5× ULN and ALT ≤1.5× ULN, f. INR/PT and aPTT ≤1.5× ULN, g. Serum amylase and lipase ≤1.5× ULN, h. serum albumin ≥3.0 g/dL (30 g/L), and i. CCR ≥30 ml/min. Clinically significant heart and CNS disorders, including acute myocardial infarction within 6 months before Cycle 1 Day 1, congestive heart failure as Class III or IV by the New York Heart Association, unstable angina, uncontrolled arrhythmias requiring further treatment, stroke, or brain hemorrhage.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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