Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Registration Number
- NCT06194656
- Lead Sponsor
- Shanghai Institute Of Biological Products
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria:<br><br> - The subjects voluntarily participated in the study and signed the informed consent.<br><br> - Male and female aged between 18 and 75 years old, regardless of gender.<br><br> - Patients with recurrent/metastatic advanced HNSCC who have been diagnosed by<br> histology or cytology, progressed or intolerant after previous immunotherapy<br> containing anti-PD-1/anti-PD-L1 and platinum, and have no indication of radical<br> local treatment. Subjects should not receive more than 2 lines of treatment in the<br> past.<br><br> - During the screening period, subjects must provide tumor tissues and blood samples<br> for biomarker detection. If the subject does not have an archived tumor tissue<br> sample, he or she will undergo a fresh tumor biopsy during the screening period to<br> obtain the corresponding tumor sample. If the subject can't provide archived or<br> fresh tumor tissue samples, but can provide the previous test reports of qualified<br> institutions, including all biomarker indicators specified in this scheme, they can<br> be screened after communicating with the sponsor.<br><br> - There must be at least one measurable lesion as the target lesion (according to<br> RECIST v1.1 standard). Tumor lesions located in previous radiotherapy areas or other<br> local regional treatment sites are generally not measurable lesions unless the<br> lesion has definite progression.<br><br> - The ECOG physical fitness score is 0-1.<br><br> - The laboratory test results meet the requirements.<br><br> - The expected survival time is = 3 months.<br><br> - In fertile female subjects, the blood pregnancy test must be negative within 7 days<br> before the first medication. Subjects of reproductive age (including male subjects)<br> had no family planning during the trial period and within 6 months after the last<br> administration and voluntarily took effective contraceptive measures.<br><br>Exclusion Criteria:<br><br> - The primary site of squamous cell carcinoma is nasal cavity, paranasal sinuses,<br> nasopharynx and salivary gland.<br><br> - The participant has received any HER3 targeting or EGFR targeting therapy in the<br> past.<br><br> - Active central nervous system metastasis and/or meningeal metastasis.<br><br> - Previous allergy to human normal immunoglobulin or antibody preparation or other<br> serious infusion reaction; Severe hypersensitivity disease, allergic constitution.<br><br> - In the past 5 years, the subjects had suffered from malignant tumors other than<br> those treated in this study (except cured thyroid cancer, skin basal cell carcinoma<br> and cervical carcinoma in situ).<br><br> - People infected with active human immunodeficiency virus (HIV), hepatitis C virus<br> (HCV), hepatitis B vrius (HBV), syphilis or active tuberculosis, and asymptomatic<br> chronic hepatitis B or hepatitis C carriers may be excluded.<br><br> - The subjects have not recovered from the toxicity of previous anti-tumor therapy to<br> grade = 1 or baseline level (except participants with hair loss, neuropathy of grade<br> = 2 or stabilized thyroid function's decline by hormon replacement therapy).<br><br> - Subjects are currently participating in and receiving research treatment or have<br> been treated with other research drugs or medical devices within 4 weeks before the<br> first use of research drugs.<br><br> - Patients who plan to receive any other anti-tumor treatment during the trial should<br> be excluded.<br><br> - Major surgery, radiotherapy (except palliative radiotherapy for targeted bone<br> metastasis), or treatment such as unhealed surgical wound, ulcer or fracture within<br> 4 weeks before the first administration; Received Chinese patent medicines or<br> Chinese herbal medicines with anti-tumor indications within 2 weeks before the first<br> administration; Chemotherapy was received within 3 weeks before the first<br> administration, and anti-tumor treatments such as biotherapy, endocrine therapy,<br> targeted therapy and immunotherapy were received within 4 weeks<br><br> - Those who have been vaccinated live within 30 days before the first administration.<br><br> - Active infections requiring systemic treatment, such as pneumonia, bacteremia,<br> septicemia, etc.<br><br> - A history of pulmonary interstitial disease, pulmonary interstitial fibrosis or<br> drug-induced interstitial pneumonia or other clinically serious lung diseases (CTCAE<br> 5.0 grade III-IV).<br><br> - Pulmonary thromboembolism, arterial thrombosis and deep vein thrombosis formation<br> (DVT) occurred within 6 months before screening, except for infusion set-related<br> thrombosis.<br><br> - Have a history or evidence of cardiovascular (CV) risk.<br><br> - During the screening period, 12-lead electrocardiogram (ECG) measurement was<br> performed in the research center (the average value of QTcF that needs to be<br> measured repeatedly for 3 times), and the QT interval (QTcF) corrected by Fridericia<br> method was > 450 milliseconds (male) or (QTcF) > 470 milliseconds (female); LVEF of<br> cardiac ultrasound was less than 50%.<br><br> - Therapeutic surgery was performed within 28 days before the first administration, or<br> major surgery was expected during the study period (except diagnosis, biopsy and<br> drainage).<br><br> - People with mental disorders or poor compliance.<br><br> - Pregnant or lactating women.<br><br> - According to the researcher's judgment, there are accompanying diseases (such as<br> severe hypertension, diabetes, thyroid diseases, etc.) that seriously endanger the<br> patient's safety or affect the patient's completion of the study.<br><br> - Suffering from diseases requiring long-term treatment with high doses (defined as<br> 30mg/d hydrocortisone or equivalent doses of other hormonal drugs) of hormones or<br> immunosuppressive drugs.<br><br> - After active treatment, uncontrollable pleural and abdominal cavity or other lacunar<br> effusion.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of any adverse events (AE);SAE (Serious Adverse Events);Cmax (Peak Plasma Concentration);Tmax(Peak Time);T ½(Terminal elimination half-life);CL(Clearance Rate);Difference of ORR
- Secondary Outcome Measures
Name Time Method ORR (Objective Response Rate);DCR (Disease control rate);PFS (Progression-free survival);ADA (Anti-drug Antibody);NAb (Neutralizing Antibody)