Tolerance and Pharmacokinetics of TQB2450

NCT03460457 | Unknown Phase 1

• 1 other identifier: TQB2450-I-01
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Tumor

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose(MTD)

  21 days

• dose-limiting toxicity(DLT)

  21 days

Secondary Outcomes (6)

• 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

Study Arms (1)

TQB2450

EXPERIMENTAL

Drug: TQB2450

Interventions

TQB2450 DRUG

Pharmacokinetics/Dynamics Study

TQB2450

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment;
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 38188467 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 9, 2018
• Study Start: March 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-03