RecruitingPhase 2NCT07101744

Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial

Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic Nasopharyngeal Carcinoma After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

41 participants

Start Date

Oct 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC). It is expected to investigate a novel therapeutic regimen with improved efficacy and enhanced safety for recurrent/metastatic NPC, thereby providing robust evidence-based medical support for the application of dual-target immune checkpoint inhibitors in nasopharyngeal carcinoma therapy


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three immunotherapy drugs — iparomlimab, tuvonralimab, and nimotuzumab — in people with nasopharyngeal cancer (a type of head and neck cancer) that has come back or spread after first-line chemotherapy. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with nasopharyngeal carcinoma confirmed by biopsy - Your cancer has come back locally, spread to other parts of the body, or was diagnosed at an advanced stage from the start - Your cancer has failed first-line platinum-based chemotherapy (with or without immunotherapy) - You have at least one measurable tumor on MRI **You may NOT be eligible if...** - Your overall health is too poor (ECOG performance score above 1) - Your liver, kidneys, or blood counts are outside safe ranges - You have active autoimmune disease or are on steroids 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.

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Interventions

DRUGIparomlimab and Tuvonralimab

Iparomlimab and Tuvonralimab combined with Nimotuzumab , administered on Day 1 every 3 weeks (D1 Q3W), until disease progression or unacceptable toxicity.


Locations(1)

Sun Yat-sen University Cancer Center

Guangdong, China

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NCT07101744


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