NCT07090317

Iparomlimab and Tuvonralimab in HNSCC

Iparomlimab and Tuvonralimab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Failed Second-line Treatment:A Prospective, Single Arm, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, non-randomized, prospective phase II clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab in patients with with recurrent/metastatic head and neck squamous cell carcinoma failed second-line treatment. The participants would receive cetuximab combined with Iparomlimab and Tuvonralimab until termination criteria are met.

Conditions

• Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab	The administration regimen of Iparomlimab and Tuvonralimab is: the recommended dose of Iparomlimab and Tuvonralimab is 5mg/kg, intravenous infusion, with a treatment cycle of 21 days. The subjects will continue to receive treatment with Iparomlimab and Tuvonralimab until the termination criteria are met.

Timeline

• Start date: 2025-07-31
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-07-29
• Last updated: 2025-07-31

Locations

1 site across 1 country: China