Trial Title:
Clinical Trial of TQB3002 in Patients With Advanced Cancers
NCT ID:
NCT06662760
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3002 Tablets
Description:
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.
Arm group label:
TQB3002 Tablets
Summary:
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in
subjects with advanced cancers
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510180
Country:
China
Contact:
Last name:
Qing Zhou, Doctor
Phone:
020-83827812
Email:
zhouqing@gdph.org.cn
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Contact:
Last name:
Yanqiu Zhao, Doctor
Phone:
13938252350
Email:
13938252350@163.com
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Contact:
Last name:
Renhua Guo, Master
Phone:
13585145540
Email:
guorenhua@csco.ac.cn
Facility:
Name:
The First Affiliated Hospital Of Nanchang University
Address:
City:
Nanchang
Zip:
330038
Country:
China
Contact:
Last name:
Longhua Sun, Doctor
Phone:
18279110112
Email:
48570887@qq.com
Contact backup:
Last name:
Jinhua Wen, Doctor
Phone:
13970823367
Email:
wenjh8606@163.com
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Contact:
Last name:
Shengxiang Ren, Doctor
Phone:
13816756732
Email:
harry_ren@126.com
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710004
Country:
China
Contact:
Last name:
Hui Guo, Doctor
Phone:
13572824106
Email:
guohuihappy97@163.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiao Tong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Contact:
Last name:
Yu Yao, Doctor
Phone:
13572101611
Email:
Oncology_yao@163.com
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610040
Country:
China
Contact:
Last name:
Juan Li, Doctor
Phone:
13570431657
Facility:
Name:
Mianyang Central Hospital
Address:
City:
Mianyang
Zip:
621099
Country:
China
Contact:
Last name:
Yu Zhang, Doctor
Phone:
15228700888
Email:
543703371@qq.com
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Contact:
Last name:
Runxiang Yang, Master
Phone:
13888876721
Email:
13888876721@163.com
Start date:
November 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06662760
