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

NCT07677475 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-08-05

No results posted yet for this study

Summary

This is a multicenter, prospective, randomized, controlled Phase II trial evaluating the safety and efficacy of MRG003 (Becotatug vedotin) combined with Toripalimab versus Toripalimab alone as neoadjuvant therapy for PD-L1-positive, resectable locally advanced head and neck squamous cell carcinoma. A total of 65 subjects are planned (43 experimental, 22 control). The experimental arm receives two cycles of MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on Day 1 followed by Toripalimab 240 mg intravenously on Day 1 every 3 weeks, while the control arm receives two cycles of Toripalimab 240 mg alone. After neoadjuvant therapy, both arms undergo radical surgery 3-4 weeks later, followed by risk-adapted adjuvant radiotherapy or chemoradiotherapy with concurrent Toripalimab (3 cycles) and then 12 cycles of adjuvant Toripalimab maintenance. The primary endpoint is the major pathological response rate.

Conditions

Interventions

DRUG

MRG003 (Becotatug vedotin) and Toripalimab

Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle, followed immediately by MRG003 (Becotatug vedotin) 2.0 mg/kg (based on actual body weight) administered intravenously without prophylactic premedication. Neoadjuvant phase: 2 cycles of both drugs. Adjuvant toripalimab: 3 cycles concurrent with radiotherapy, then 12 cycles maintenance. For MRG003 (Becotatug vedotin), monitor infusion reactions for at least 120 minutes after first dose and at least 60 minutes after subsequent doses if tolerated. Dose reduction of MRG003 (Becotatug vedotin) to 1.5 mg/kg is permitted once for toxicity; permanent discontinuation if intolerance persists at reduced dose. Toripalimab dose remains fixed throughout; no dose modification is permitted.

DRUG

Toripalimab

Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle. Neoadjuvant phase: 2 cycles. Adjuvant phase (concurrent with radiotherapy): 3 cycles. Adjuvant maintenance (after radiotherapy): 12 cycles. No prophylactic premedication required. No dose modification of toripalimab is permitted.

Sponsors & Collaborators

  • Sun Yat-Sen University Cancer Center

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • The University of Hong Kong-Shenzhen Hospital

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Dongguan People's Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhigang Liu, MD · The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2029-01-30
Completion
2029-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07677475 on ClinicalTrials.gov