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.
Study summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Dose Limiting Toxicity (DLT) — During the first 28 days DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28days) of treatment.
Maximum tolerated dose (MTD) — During the first 28 days MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Trial sites (11)
Facility
City
Region
Status
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen
Guangdong
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Not Yet Recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Not Yet Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an
Shanxi
Not Yet Recruiting
Sichuan Cancer Hospital
Chengdu
Sichuan
Not Yet Recruiting
Mianyang Central Hospital
Mianyang
Sichuan
Not Yet Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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