A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
- Registration Number
- NCT03754244
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent
Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs 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; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3456 TQB3456 p.o. qd
- Primary Outcome Measures
Name Time Method Dose-Limiting Toxicities（DLT） Baseline up to 28 days an adverse event cccurring after initiation of TQ-B3456 that met any following criteria：
1. \>=Grade 3 of non-hematology toxicity
2. Grade 4 hematology toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
No. 241 Huaihai West Road, Xuhui District, Shanghai
🇨🇳Shanghai, Shanghai, China