Recruiting NCT06662760

Clinical Trial of TQB3002 in Patients With Advanced Cancers

Phase I Interventional Advanced Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: TQB3002 Tablets.
Who it may be relevant to: Registry conditions: Advanced Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers

Drug TQB3002 Tablets
TQB3002 is a fourth-generation small molecule Epidermal growth factor receptor (EGFR) inhibitor, which inhibits relevant tyrosine kinase activity and intracellular phosphorylation process by competitively binding to Adenosine triphosphate (ATP) site of intracellular tyrosine kinase binding domain, thereby inhibiting EGFR downstream signaling, ultimately achieving the purpose of inhibiting tumor growth.

Secondary outcome measures (5)

Half-life (T1/2) [Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
The area under the curve (AUC) [Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
Apparent Plasma Clearance (CL) [Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
Apparent volume of distribution (Vz) [Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]
Minimum concentration (Cmin) [Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration]

Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
Age: ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
Histologically or cytologically diagnosed with advanced cancers
Subjects with advanced malignancies who have failed standard therapy or lack effective treatment
Major organs are functioning well；
Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Current concomitant presence of other malignancies within 5 years prior to the first dose；
Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose
Long-term unhealed wounds or fractures
Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose
Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
Subjects with any severe and/or uncontrolled disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 11 centers

NCT: NCT06662760 · TQB3002-I-01