Tolerance and Pharmacokinetics of TQB2450

NCT ID: NCT03460457

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2019-03-15

Brief Summary

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

Conditions

Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2450

Group Type: EXPERIMENTAL

TQB2450

Intervention Type: DRUG

Pharmacokinetics/Dynamics Study

Interventions

TQB2450

Pharmacokinetics/Dynamics Study

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Xue J, Xue L, Tang W, Ge X, Zhao W, Li Q, Peng W, Dai C, Guo Y, Li J. TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study. Ther Adv Med Oncol. 2024 Jan 6;16:17588359231220516. doi: 10.1177/17588359231220516. eCollection 2024.

Reference Type: DERIVED

PMID: 38188467 (View on PubMed)

Other Identifiers

TQB2450-I-01

Identifier Type: -

Identifier Source: org_study_id