Clinical Trial of TQB3002 in Patients With Advanced Cancers
A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
150 participants
Dec 9, 2024
INTERVENTIONAL
Conditions
Summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria8
- 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
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Interventions
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.
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06662760