Clinical Trial of TQB3002 in Patients With Advanced Cancers
- Registration Number
- NCT06662760
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
- Age: 18-75 years; 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3002 Tablets TQB3002 Tablets TQB3002 Tablets, 28 days as a treatment cycle
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (10)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital Of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shanxi, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Mianyang Central Hospital
🇨🇳Mianyang, Sichuan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China