A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03754244
• Other study ID #: TQB3456-I-01
• Status: Terminated
• Phase: Phase 1
• Start date: September 24, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

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Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• TQB3456
Observe the safety and pk when the subjects take TQB3456 p.o. qd

Locations

Country	Name	City	State
China	No. 241 Huaihai West Road, Xuhui District, Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicities(DLT)	an adverse event cccurring after initiation of TQ-B3456 that met any following criteria: >=Grade 3 of non-hematology toxicity; Grade 4 hematology toxicity	Baseline up to 28 days