This is a multicenter, randomized, open-label, controlled Phase 2 trial evaluating neoadjuvant MRG003 (anti-EGFR ADC) plus toripalimab versus toripalimab alone in PD-L1-positive (CPS ≥ 1), resectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Patients are randomized 2:1 to receive 2 cycles of MRG003 2.0 mg/kg IV plus toripalimab 240 mg IV Q3W (n=43) or toripalimab 240 mg IV Q3W alone (n=22), followed by surgery and risk-adapted adjuvant therapy including radiotherapy and toripalimab maintenance. The primary endpoint is Major Pathological Response (MPR) rate. Secondary endpoints include pCR, ORR, EFS, R0 resection rate, surgical down-staging, and safety. Enrolling 65 participants across 11 centers in China.
Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1)
Treatment-naïve, pathologically confirmed stage III-IVA resectable non-oropharyngeal HNSCC (oral cavity, larynx, hypopharynx) OR HPV-negative oropharyngeal SCC, OR HPV-positive stage III T4N0-2 resectable oropharyngeal cancer (AJCC 8th edition)
No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
Age 18 to 70 years
None
Parallel
MRG003 and Toripalimab
DrugNeoadjuvant MRG003 (2.0 mg/kg IV Q3W) plus Toripalimab (240 mg IV Q3W for 2 cycles), followed by radical surgery and risk-adapted adjuvant therapy.
Toripalimab
DrugNeoadjuvant Toripalimab (240 mg IV Q3W for 2 cycles), followed by radical surgery and risk-adapted adjuvant therapy.
Major Pathological Response (MPR) rate
Proportion of patients with major pathological response, defined as ≤ 10% residual viable tumor in the primary tumor and all sampled lymph nodes after completion of neoadjuvant therapy.
Event-Free Survival (EFS)
Time from randomization to first documented radiographic progression, progression leading to inoperability, or death from any cause.
Pathologic Complete Response (pCR) Rate
Proportion of subjects with no residual viable tumor cells in the primary tumor bed or resected lymph nodes after neoadjuvant therapy.
Objective Response Rate (ORR) per RECIST 1.1
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST 1.1 after 2 cycles of neoadjuvant therapy.
Safety: Incidence of Adverse Events and Serious Adverse Events
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) graded by CTCAE v5.0.
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Dongguan People's Hospital
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Shenzhen People's Hospital
Collaborator
Peking University Shenzhen Hospital
Collaborator
The University of Hong Kong-Shenzhen Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Huizhou Municipal Central Hospital
Collaborator
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