Tumor
Conditions
Brief summary
To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.
Interventions
DRUGTQB2450
Pharmacokinetics/Dynamics Study
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose(MTD) | 21 days |
| dose-limiting toxicity(DLT) | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Half life（t1/2） | 21 days |
| Area under the plasma concentration versus time curve (AUC) | 21 days |
| Peak Plasma Concentration(Cmax) | 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) |
| Clearance（CL） | 21 days |
| Peak time（Tmax） | 21 days |
Outcome results
None listed