Tolerance and Pharmacokinetics of TQB2450

Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection

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

Study Overview

• Status: Unknown
• Conditions: Tumor
• Intervention / Treatment: Drug: TQB2450

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2450	Drug: TQB2450; Pharmacokinetics/Dynamics Study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2018
• Primary Completion (Anticipated): March 15, 2019
• Study Completion (Anticipated): March 15, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TQB2450-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No