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

Launched by BEIJING TONGREN HOSPITAL · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), a type of cancer that affects areas like the mouth, throat, and voice box. The study is testing a combination of two drugs, Finotonlimab and Stapokibart, to see if they are safe and effective for patients whose cancer has returned or spread after they have already received certain standard treatments. This is an early-phase trial, meaning researchers are primarily looking at safety and how well the treatment works.

To be eligible, participants need to be adults (18 years or older) with confirmed recurrent or metastatic HNSCC in specific head and neck areas. They must have previously been treated with a type of immunotherapy called PD-1 inhibitors, either alone or with chemotherapy, and have experienced cancer progression within about three months after that treatment. Participants should be in generally good health with adequate organ function and no serious infections or other major health issues. If accepted, patients will receive the study drugs and be closely monitored for side effects and how their cancer responds to the treatment. It’s important to note that this trial is not yet recruiting, so those interested should stay in touch with their healthcare providers for updates.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign the ICF;
• • 2. Recurrent/metastatic HNSCC diagnosed histologically or cytologically in the oral, oropharyngeal, pharyngeal, and laryngeal regions;
• • 3. Male/female, ≥ 18 years old, ECOG 0\~1;
• • 4. After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 12 weeks after the last ICI administration (as assessed by RECIST 1.1);
• • 5. Target lesion (RECIST 1.1);
• • 6. Previous PD-L1 expression test results may provide tissue for PD-L1 immunohistochemical testing;
• • 7. Expected to survive for more than 3 months;
• 8. 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 × 109/L; b) Platelets ≥ 75 × 109/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.
• Exclusion Criteria:
• • 1. Suitable for local treatment;
• • 2. Merge with other malignant tumors;
• • 3. Brain metastasis;
• • 4. If the toxicity does not recover to level 0-1 after surgery/radiotherapy/drug treatment, excluding chronic toxicity;
• • 5. Allergic to known medication ingredients;
• • 6. Major surgeries, radiation therapy (excluding palliative care), chemotherapy, immunotherapy, and biologics within 4 weeks prior to enrollment;
• • 7. Received TKI, palliative surgery, and non-specific immunomodulatory therapy (such as thymosin and interferon) within 2 weeks before enrollment;
• • 8. Received traditional Chinese patent medicines and simple preparations within one week before enrollment;
• • 9. Use immunosuppressive drugs within 4 weeks before enrollment (excluding short-term, local, and physiological dose hormone therapy);
• 10. 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.
• • 11. Uncontrollable pleural effusion, abdominal effusion, and pericardial effusion;
• • 12. Previous grade ≥ 3 irAE or grade ≥ 2 myocarditis;
• 13. 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 milliseconds; Echocardiography (ECHO) indicates that the subject's left ventricular ejection fraction (LVEF) is less than 50%; New York Heart Association (NYHA) heart function classification ≥ 2; Clinically uncontrollable hypertension (note: diastolic blood pressure ≥ 100mmHg or systolic blood pressure ≥ 160mmHg. 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;
• • 14. Active autoimmune diseases;
• • 15. There is a significant risk of bleeding;
• • 16. Receive a live vaccine within 4 weeks before enrollment;
• • 17. During pregnancy or lactation, subjects with fertility do not receive contraceptive measures;
• • 18. The presence of mental illness may affect the conduct of clinical trials;
• • 19. History of organ transplantation or stem cell transplantation.