Tolerance and Pharmacokinetics of TQB2450

Study Overview
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Brief Summary
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To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.

Official Title
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Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection

Conditions
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Tumor

Intervention / Treatment
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* Drug: TQB2450


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment; 18-70 years old;Eastern Cooperative Oncology Group performance status:0-1,Life expectancy of more than 3 months; Main organs function is normal; Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped; Patients should be voluntary and sign the informed consents before taking part in the study; Exclusion Criteria: Patients who have received programmed cell death protein 1(PD-1) or programmed cell death protein ligand(PD-L1) antibody treatment; Patients who had any> 3 degree immune-related adverse event during any previous immunotherapy received; Appeared severe hypersensitivity after taking other monoclonal antibody drugs; Other malignancies have been diagnosed in the past 2 years except cured or locally curable cancers, such as cutaneous or squamous cell carcinoma, superficial bladder cancer, cervical cancer or orthotopic carcinoma of the breast; Known spinal cord compression, cancer meningitis patients, new onset of central nervous system metastasis or stable control of symptoms in patients with brain metastases less than 4 weeks; asymptomatic and stable imaging without the need for corticosteroid treatment； Patients with hypothyroidism over 2 degrees; Patients with active, or who have had, and are likely to relapse, autoimmune diseases; the following patients are enrolled: skin disorders without systemic treatment (eg vitiligo, psoriasis, hair loss); Patients treated with glucocorticoids or other immunosuppressive agents within 4 weeks prior to dosing; Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis; Serious chronic or active infections require systemic antibacterial, antifungal or antiviral treatment (allowing antiviral treatment in patients with hepatocellular carcinoma), including tuberculosis infection; Unstable pleural effusion, pericardial effusion or ascites; Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history; Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C; The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives; The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives; Inoculated with vaccine or attenuated vaccine within 4 weeks before first administration; Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQB2450<br> | Drug: TQB2450<br>* Pharmacokinetics/Dynamics Study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose(MTD) |  | 21 days | 
| dose-limiting toxicity(DLT) |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration(Cmax) |  | 21 days | 
| Peak time（Tmax） |  | 21 days | 
| Half life（t1/2） |  | 21 days | 
| Area under the plasma concentration versus time curve (AUC) |  | 21 days | 
| Clearance（CL） |  | 21 days | 
| objective response rate(ORR) |  | evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months) |