Tolerance and Pharmacokinetics of TQB2450
Study Details
Study Description
Brief Summary
To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TQB2450
|
Drug: TQB2450
Pharmacokinetics/Dynamics Study
|
Outcome Measures
Primary Outcome Measures
- maximum tolerated dose(MTD) [21 days]
- dose-limiting toxicity(DLT) [21 days]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment;
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18-70 years old;Eastern Cooperative Oncology Group performance status:0-1,Life expectancy of more than 3 months;
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Main organs function is normal;
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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;
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Patients should be voluntary and sign the informed consents before taking part in the study;
Exclusion Criteria:
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Patients who have received programmed cell death protein 1(PD-1) or programmed cell death protein ligand(PD-L1) antibody treatment;
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Patients who had any> 3 degree immune-related adverse event during any previous immunotherapy received;
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Appeared severe hypersensitivity after taking other monoclonal antibody drugs;
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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;
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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；
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Patients with hypothyroidism over 2 degrees;
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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);
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Patients treated with glucocorticoids or other immunosuppressive agents within 4 weeks prior to dosing;
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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;
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Serious chronic or active infections require systemic antibacterial, antifungal or antiviral treatment (allowing antiviral treatment in patients with hepatocellular carcinoma), including tuberculosis infection;
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Unstable pleural effusion, pericardial effusion or ascites;
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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;
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Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
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Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication;
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Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C;
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The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;
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The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;
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Inoculated with vaccine or attenuated vaccine within 4 weeks before first administration;
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Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TQB2450-I-01