NCT06530914

A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lei Liu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.

Detailed description

In this study, eligible patients will be randomized in a 1:1 ratio to either the MRG003 Injection Combined With Pucotenlimab Injection treatment group (Cohort 1), or the MRG003 Injection Combined With Pucotenlimab Injection + Cisplatin treatment group (Cohort 2). Pathological response rate will be the primary outcome measures. Adverse events will also be recorded.

Conditions

• Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Type	Name	Description
DRUG	MRG003 combined with Pucotenlimab	Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
DRUG	MRG003 combined with Pucotenlimab+Cisplatin	All interventions all drugs intravenous infusion, once every 3 weeks, a total of 3 cycles.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-07-31
• Last updated: 2024-07-31