HNSCC
Conditions
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, five 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 five participants will be enrolled according to the study protocol.
Interventions
COMBINATION_PRODUCTStapokibart 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
Beijing Tongren Hospital
Sinocelltech Ltd.
Keymed Biosciences Co.Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Up to 2 years | Number of participants with AEs assessed by Common Terminology Criteria for Adverse Events v5.0. |
| Overall response rate (ORR) | Up to 2 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Up to 2 years | The proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) as their best overall response, according to RECIST 1.1 criteria. |
| Progression free survival (PFS) | Up to 2 years | PFS will be calculated from the first administration of Stapokibart to the date of documented disease progression, or death from any cause. |
| Duration of response (DOR) | Up to 2 years | The time from the date of first response (CR or PR) to the date of progression of disease or death of any cause. |
Countries
China
Contacts
CONTACTLuo Zhang
STUDY_CHAIRLuo Zhang
Beijing Tong-Ren hospital
Outcome results
None listed