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

NCT ID: NCT07040072

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-06-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stapokibart and Finotonlimab

Stapokibart, 600 mg for the first cycle, 300 mg for the second and third cycles, administered subcutaneously every three weeks, for a total of 3 doses.

Finotonlimab 200 mg, administered intravenously once every three weeks, until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Stapokibart and Finotonlimab

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: collaborator

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luo Zhang

Role: STUDY_CHAIR

Beijing Tong-Ren hospital

Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Luo Zhang

Role: CONTACT

dr.luozhang@gmail.com

(86)13910830399

Facility Contacts

Luo Zhang

Role: primary

dr.luozhang@gmail.com

(86)13910830399

Other Identifiers

TR Sta-Fin (LONG'E)

Identifier Type: -

Identifier Source: org_study_id