MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor
Dongguan People's Hospital
Study ID
NCT07677475
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MRG003 and Toripalimab — DRUG
    Neoadjuvant 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 — DRUG
    Neoadjuvant Toripalimab (240 mg IV Q3W for 2 cycles), followed by radical surgery and risk-adapted adjuvant therapy.

Study Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jan 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MRG003 + Toripalimab
    Two cycles of neoadjuvant MRG003 (Vebecototagene Autoteucovaline) 2.0 mg/kg intravenous infusion on Day 1 plus Toripalimab 240 mg intravenous infusion on Day 1 of each 21-day cycle, followed by radical surgery and risk-adapted adjuvant therapy (radiotherapy ± concurrent cisplatin + Toripalimab maintenance up to 12 cycles).
  • Active Comparator: Toripalimab Monotherapy
    Two cycles of neoadjuvant Toripalimab 240 mg intravenous infusion on Day 1 of each 21-day cycle (monotherapy), followed by radical surgery and risk-adapted adjuvant therapy (radiotherapy ± concurrent cisplatin + Toripalimab maintenance up to 12 cycles). During adjuvant radiotherapy, 3 cycles of concurrent Toripalimab 240 mg Q3W are given.

Primary Outcome Measure

Major Pathological Response (MPR) rate [ Time Frame: At the time of surgical specimen evaluation (approximately 6-8 weeks after initiation of neoadjuvant therapy) ]

Central Contacts

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