Trial Title:
The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
NCT ID:
NCT06452706
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
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:
TQB2102 for injection
Description:
TQB2102 for injection is a HER2 dual-antibody-drug conjugate (ADC).
Arm group label:
TQB2102 for injection
Summary:
This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2
negative recurrent/metastatic breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The participants voluntarily participate in the study and sign an informed consent
form.
- Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point;
Expected survival period exceeds 3 months.
- Breast cancer patients diagnosed as HER2 negative by pathology, with evidence of
local recurrence or distant metastasis are not suitable for surgery or radiation
therapy aimed at healing.
- Sufficient tumor tissue samples must be available for HER2 evaluation by
pathologists at the main research center.
- The participants's previous treatment needs to meet the following criteria: failure
after receiving at least first-line systemic chemotherapy during the recurrence
/metastasis stage (for hormone receptor positive participants, failure after
receiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined with
endocrine therapy during the recurrence/metastasis stage.
- There exists disease progression or intolerance during or after the most recent
treatment before enrollment.
- According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard,
there should be at least one measurable lesion.
- The main organ functions well and meets certain standards.
- Female participants of childbearing age should agree to use contraceptive measures
during the study period and within 6 months after the end of the study; within 7
days prior to enrollment, the serum pregnancy test was negative and must be a non
lactating subject; male participants should agree to adopt avoidance measures during
the study period and within 6 months after the end of the study period.
Exclusion Criteria:
- Concomitant diseases and medical history:
1. Have experienced or currently suffer from other malignant tumors within 5 years
prior to the first medication use;
2. Uncontrollable toxic reactions above CTCAE level 1 caused by any previous
treatment;
3. Received significant surgical treatment or significant traumatic injury within
28 days prior to the first medication use;
4. Long term unhealed wounds or fractures;
5. Participants who have a history of interstitial lung disease/pneumonia (non
infectious) requiring steroid intervention treatment in the past, or currently
have interstitial lung disease/pneumonia, or whose screening imaging suggests
suspected interstitial lung disease/pneumonia and cannot be ruled out;
6. An arterial/venous thrombotic event occurred within 6 months prior to the first
medication use;
7. Individuals with a history of psychiatric drug abuse who are unable to quit or
have mental disorders;
8. Subjects with any severe and/or uncontrolled diseases. Rheumatoid arthritis
with joint function activity graded as Grade IV or requiring wheelchair or bed
rest.
- Tumor related symptoms and treatment:
1. Participants who have received other anti-tumor drug treatments such as
chemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before the
first medication, or who are still within the 5 half-lives of the drug
(whichever is the shortest); Participants who have previously received local
radiotherapy;
2. Received endocrine therapy or traditional Chinese patent medicines and simple
preparations with anti-tumor indications specified in the National Medical
Products Administration (NMPA) approved drug directions within 2 weeks before
the first drug use;
3. Imaging shows that the tumor has invaded important blood vessels, or the
researcher determines that the tumor is highly likely to invade important blood
vessels and cause fatal massive bleeding during subsequent studies;
4. Uncontrollable pleural effusion, ascites, and moderate or higher amounts of
pericardial effusion that require repeated drainage;
5. Known presence of cancerous meningitis or clinically active central nervous
system metastasis;
6. Severe bone damage caused by tumor bone metastasis. Suffering from lung
diseases that have been determined by the researcher to be unsuitable for
participation in this study.
- Individuals who are known to be allergic to the investigational drug or its
excipients, or allergic to humanized monoclonal antibody products.
- Individuals who have participated in and used other anti-tumor clinical trial drugs
within 4 weeks prior to the first medication use.
- According to the judgment of the researchers, there are situations that seriously
endanger the safety of the subjects or affect their completion of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Bozhou People's Hospital
Address:
City:
Bozhou
Zip:
236804
Country:
China
Contact:
Last name:
Xiangde Jiang, Doctor
Phone:
13966536556
Email:
13966536556@163.com
Facility:
Name:
Chuzhou First People's Hospital
Address:
City:
Chuzhou
Zip:
239001
Country:
China
Contact:
Last name:
Dongshan You, Doctor
Phone:
13955006413
Email:
19066904@qq.com
Facility:
Name:
Anhui Provincial Public Health Clinical Center
Address:
City:
Hefei
Zip:
230031
Country:
China
Contact:
Last name:
Yunhong Xia, Doctor
Phone:
15212782466
Email:
yhxia12@sina.com
Facility:
Name:
Ma'anshan People's Hospital
Address:
City:
Ma'anshan
Zip:
243000
Country:
China
Contact:
Last name:
Fangbo Cui, Doctor
Phone:
18056891015
Email:
njucuifangbo@126.com
Facility:
Name:
Wuhu Hospital Affiliated to East China Normal University
Address:
City:
Wuhu
Zip:
241399
Country:
China
Contact:
Last name:
Kewu Wang, Doctor
Phone:
15375680003
Email:
402624423@qq.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Contact:
Last name:
Qingyuan Zhang
Phone:
13313612989
Email:
sy86298276@163.com
Facility:
Name:
The Third People's Hospital of Zhengzhou
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Lige Yao, Doctor
Phone:
13693718212
Email:
577663634@qq.com
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430000
Country:
China
Contact:
Last name:
Haijun Yu, Doctor
Phone:
13971665181
Email:
doctoryhj@126.com
Facility:
Name:
The First People's Hospital of Changde City
Address:
City:
Changde
Zip:
415003
Country:
China
Contact:
Last name:
Tao Wu, Doctor
Phone:
15873644000
Email:
20689452@qq.com
Facility:
Name:
Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Contact:
Last name:
Kunwei Shen, Doctor
Phone:
13916612760
Email:
kwshen@medmail.com.cn
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Contact:
Last name:
Jin Yang, Doctor
Phone:
18991232383
Email:
yj_clinicalstudy@163.com
Facility:
Name:
Cancer Hospital Affiliated to Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830054
Country:
China
Contact:
Last name:
Bing Zhao, Doctor
Phone:
13899908184
Email:
819502412@qq.com
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
310014
Country:
China
Contact:
Last name:
Kewang Sun, Doctor
Phone:
15356182389
Email:
sunkewangwk@hotmail.com
Facility:
Name:
Suzhou Municipal Hospital
Address:
City:
Suzhou
Zip:
234099
Country:
China
Contact:
Last name:
Xiyong Wang, Doctor
Phone:
19805571600
Email:
xy9026@qq.com
Facility:
Name:
Wenzhou Medical University Affiliated First Hospital
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Contact:
Last name:
Ouchen Wang, Doctor
Phone:
13957706099
Email:
woc099@163.com
Start date:
November 2024
Completion date:
June 2028
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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/NCT06452706
