Advanced Cancer
Conditions
Brief summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
Interventions
DRUGTQB3002 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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Half-life (T1/2) | Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration | Terminal half-life (T1/2) |
| The area under the curve (AUC) | 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) of serum concentration of TQB3002 |
| Apparent Plasma Clearance (CL) | 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 of TQB3002 |
| Apparent volume of distribution (Vz) | 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 ratio of the amount of TQB3002 in the body to the blood concentration |
| Minimum concentration (Cmin) | 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 observed concentration (Cmin) of TQB3002 |
Countries
China
Contacts
Primary ContactQing Zhou, Doctor
Outcome results
None listed