Finotonlimab plus Stapokibart for recurrent or metastatic head and neck cancer

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

This trial will see if combining Finotonlimab with Stapokibart helps adults with recurrent or metastatic head and neck squamous cell carcinoma who progressed after PD‑1 therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tongren Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Finotonlimab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07040072 on ClinicalTrials.gov

What this trial studies

This is a single‑arm phase Ib trial testing the safety and early activity of combining Finotonlimab with Stapokibart in patients with recurrent or metastatic HNSCC after prior PD‑1 ± platinum therapy. Ten participants will be enrolled at Beijing Tongren Hospital: five will start the combination regimen and investigators will conduct a planned safety review after the third participant completes the third treatment cycle. Based on that review the protocol allows dose, schedule, or sample size adjustments or termination before enrolling the remaining five participants. The study's primary focus is safety with exploratory measures of tumor response and progression per RECIST 1.1.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with recurrent or metastatic HNSCC who progressed within 24 weeks after PD‑1‑based therapy, have ECOG 0–1, measurable disease, and adequate organ function.

Not a fit: Patients who have not received prior PD‑1 therapy, who progressed outside the 24‑week window, have poor performance status, or have life expectancy under three months are unlikely to benefit or will be ineligible.

Why it matters

Potential benefit: If successful, the combination could offer a new option for patients whose head and neck cancer progressed after PD‑1 therapy by controlling tumor growth or delaying progression.

How similar studies have performed: Other early‑phase trials combining immune agents or targeted drugs in PD‑1–resistant HNSCC have shown mixed results, and this specific Finotonlimab‑Stapokibart combination is novel with limited prior data.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the ICF;
2. Recurrent/metastatic HNSCC of the oral cavity, 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 24 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 × 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.

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. Use immunosuppressive drugs within 4 weeks before enrollment (excluding short-term, local, and physiological dose hormone therapy);
9. 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.
10. Uncontrollable pleural effusion, abdominal effusion, and pericardial effusion;
11. Previous grade ≥ 3 irAE or grade ≥ 2 myocarditis;
12. 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;
13. Active autoimmune diseases;
14. There is a significant risk of bleeding;
15. Receive a live vaccine within 4 weeks before enrollment;
16. During pregnancy or lactation, subjects with fertility do not receive contraceptive measures;
17. The presence of mental illness may affect the conduct of clinical trials;
18. History of organ transplantation or stem cell transplantation.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Luo Zhang

Conditions HNSCC