NCT07040072

Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC

The Safety and Efficacy of Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, a Phase Ib Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent/metastatic HNSCC patients.

Detailed description

This study includes a total of 10 participants. Firstly, three participants will be enrolled to receive the combination therapy regimen. Safety observations will be conducted within 30 days after the third participant completes the third cycle of Stapokibart and Finotonlimab combination therapy. Based on the collected trial data, the investigators will evaluate and provide a safety report. If a major safety event or other factor affecting participant safety was identified, the treatment regimen will be re-evaluated before proceeding with further enrollment. Adjustments to administration frequency, dosage, and sample size can be made, or the trial can be terminated; If no safety concerns are identified, the remaining seven participants will be enrolled according to the study protocol.

Conditions

• HNSCC

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Stapokibart and Finotonlimab	Receive the combination of Stapokibart and Finotonlimab in cycles 1-3, and maintain treatment with Finotonlimab in subsequent cycles. Stapokibart, 600mg for the first cycle, 300mg for the second and third cycles, administered subcutaneously every 3 weeks, for a total of 3 doses of Stapokibart; Finotonlimab 200mg, administered intravenously every 3 weeks until confirmed disease progression occurs according to the RECIST 1.1 imaging criteria (if the researcher determines that the subject can benefit from continuing PD-1 drug treatment, and the subject can tolerate the study treatment and agree, PD-1 drug can be continued and recorded in the study records), unacceptable toxic side effects, initiation of new anti-tumor treatment, withdrawal from the study or death (whichever occurs first), or reaching a maximum treatment period of 2 years.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: China