Clinical trial NCT03460457: Tolerance and Pharmacokinetics of TQB2450
Official title: Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tumor
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Primary outcomes:
measure: maximum tolerated dose(MTD)
timeFrame: 21 days
measure: dose-limiting toxicity(DLT)
timeFrame: 21 days
Secondary outcomes:
measure: Peak Plasma Concentration(Cmax)
timeFrame: 21 days
measure: Peak time（Tmax）
timeFrame: 21 days
measure: Half life（t1/2）
timeFrame: 21 days
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 21 days
measure: Clearance（CL）
timeFrame: 21 days
measure: objective response rate(ORR)
timeFrame: evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months)
Other outcomes:
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