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

NCT07040072 | Recruiting Phase 1

• 1 other identifier: TR Sta-Fin (LONG'E)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  Number of participants with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.

  Up to 2 years

• Overall response rate (ORR)

  Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1).

  Up to 2 years

Secondary Outcomes (3)

• Disease control rate (DCR)

  Up to 2 years

• Progression free survival (PFS)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

Other Outcomes (4)

• Histopathological evaluation of tumor tissues

  Up to 10 weeks

• Change in proportions of tumor-infiltrating immune cell subtypes

  up to 10 weeks

• Change in serum cytokine concentrations from baseline to Week 10

  up to 10 weeks

Study Arms (1)

Stapokibart and Finotonlimab

EXPERIMENTAL

Stapokibart, 600 mg for the first cycle, 300 mg for the second and subsequent cycles, administered subcutaneously every three weeks. Finotonlimab 200 mg, administered intravenously once every three weeks, until disease progression or unacceptable toxicity.

Combination Product: Stapokibart and Finotonlimab

Interventions

Stapokibart and Finotonlimab COMBINATION_PRODUCT

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.

Stapokibart and Finotonlimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the ICF;
• Recurrent/metastatic HNSCC of the oral cavity, oropharyngeal, pharyngeal, and laryngeal regions;
• Male/female, ≥ 18 years old, ECOG 0\~1;
• After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 24 weeks after the last ICI administration (as assessed by RECIST 1.1);
• Target lesion (RECIST 1.1);
• Previous PD-L1 expression test results may provide tissue for PD-L1 immunohistochemical testing;
• Expected to survive for more than 3 months;
• The main organ functions must meet the following requirements (laboratory test values within 7 days before enrollment must meet the following standards):
• Blood routine examination: (No blood transfusion, no use of granulocyte colony-stimulating factor, no medication correction within 14 days before screening): a) Neutrophils ≥ 1.5 × 10\^9/L; b) Platelets ≥ 75 × 10\^9/L; c) Hemoglobin ≥ 90g/L; ② Biochemical examination: (No albumin transfusion within 14 days before screening): a) Blood creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance rate\>50 mL/min; b) Serum total bilirubin ≤ 1.5 × ULN; c) Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ③ Coagulation function: a) International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the normal control range ≤ 6 seconds.

You may not qualify if:

• Suitable for local treatment;
• Merge with other malignant tumors;
• Brain metastasis;
• If the toxicity does not recover to level 0-1 after surgery/radiotherapy/drug treatment, excluding chronic toxicity;
• Allergic to known medication ingredients;
• Major surgeries, radiation therapy (excluding palliative care), chemotherapy, immunotherapy, and biologics within 4 weeks prior to enrollment;
• Received TKI, palliative surgery, and non-specific immunomodulatory therapy (such as thymosin and interferon) within 2 weeks before enrollment;
• Use immunosuppressive drugs within 4 weeks before enrollment (excluding short-term, local, and physiological dose hormone therapy);
• Patients with the following infection conditions:
• Active infections require systemic use of antibiotics; Active mycobacterium tuberculosis infection (i.e. tuberculosis infection); Hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive; Hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥ 1000 IU/mL; History of human immunodeficiency virus (HIV) infection or HIV antibody positivity during screening period.
• Uncontrollable pleural effusion, abdominal effusion, and pericardial effusion;
• Previous grade ≥ 3 irAE or grade ≥ 2 myocarditis;
• Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to:
• Major cardiovascular and cerebrovascular diseases (such as congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism, etc.) occurred within 6 months before the first administration; Corrected QT interval (QTcF)\>480 msec; Echocardiography (ECHO) indicates that the subject's left ventricular ejection fraction (LVEF) \< 50%; New York Heart Association (NYHA) heart function classification ≥ 2; Clinically uncontrollable hypertension (If blood pressure is controlled with or without intervention, subjects can continue to be screened); Other cardiovascular and cerebrovascular diseases that have been evaluated by the researchers as unsuitable for participation in this study;
• Active autoimmune diseases;

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Keymed Biosciences Co.Ltd: collaborator
• Sinocelltech Ltd.: collaborator

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Luo Zhang

  Beijing Tong-Ren hospital

  STUDY CHAIR

Central Study Contacts

Luo Zhang

CONTACT

(86)13910830399; dr.luozhang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: June 26, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2025-06

Locations

CN (1)