Tolerance and Pharmacokinetics of TQB2450

Tumor Clinical Trial

Official title:

Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03460457
• Other study ID #: TQB2450-I-01
• Status: Not yet recruiting
• Phase: Phase 1
• First received: February 26, 2018
• Last updated: March 2, 2018
• Start date: March 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2018
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• TQB2450
Pharmacokinetics/Dynamics Study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Outcome

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