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

NCT07040072 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • HNSCC

Interventions

COMBINATION_PRODUCT

Stapokibart and Finotonlimab

Receive the combination therapy with Stapokibart and Finotonlimab. Stapokibart, 600mg for the first cycle, 300mg for the second and subsequent cycles, administered subcutaneously every 3 weeks; Finotonlimab 200mg, administered intravenously every 3 weeks. Treatment with Stapokibart in combination with Finotonlimab was continued 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.

Sponsors & Collaborators

  • Sinocelltech Ltd.

    collaborator INDUSTRY

  • Keymed Biosciences Co.Ltd

    collaborator INDUSTRY

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Luo Zhang · Beijing Tong-Ren hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040072 on ClinicalTrials.gov