RecruitingPhase 2NCT07090317

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


Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Enrollment

30 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination immunotherapy — iparomlimab plus tuvonralimab (two checkpoint inhibitor drugs that work on different immune pathways) — in people with recurrent or metastatic head and neck squamous cell carcinoma that has already progressed after two or more lines of treatment. **You may be eligible if...** - You are 18–75 years old - You have a confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, or larynx) - Your cancer has progressed after 2 or more prior systemic treatments - You have adequate organ function and a good performance status (ECOG 0–1) - You have measurable disease **You may NOT be eligible if...** - You have not had prior systemic treatment for metastatic/recurrent disease - You have active autoimmune disease - You are pregnant or breastfeeding - You have uncontrolled infections or other cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIparomlimab 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.


Locations(1)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07090317


Related Trials