Trial Title:
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
NCT ID:
NCT06431490
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
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:
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients
with Her2-positive biliary tract cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
- Test subjects with HER2 expression or amplification or mutation require
immunohistochemistry of HER2 3+ or HER2 2 and positive for in situ hybridization
(ISH);
- The main organs function well;
- Meet the criteria for advanced biliary tract cancer:
1. Biliary tract carcinoma confirmed by histology or cytology;
2. Non-operable locally advanced, recurrent and/or metastatic disease with at
least one measurable lesion according to Evaluation criteria for the efficacy
of solid tumors (RECIST) 1.1 criteria;
3. Failure of previous standard treatment.
- Women of reproductive age should agree that effective contraception must be used
during the study period and for 6 months after the end of the study, and that serum
or urine pregnancy tests are negative within 7 days prior to study enrollment; Men
should agree that effective birth control must be used during the study period and
for 6 months after the end of the study period;
- The subjects voluntarily joined the study, signed the informed consent, and the
compliance was good.
Exclusion Criteria:
- Complicated diseases and medical history:
1. Have had or are currently suffering from other malignant tumors within 3 years
before the first medication;
2. Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria
for Adverse Events (CTCAE) due to any previous treatment;
3. Major surgical treatment, significant traumatic injury, or long-term unhealed
wounds or fractures have been received within 4 weeks prior to initial
medication;
4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks
before the first dose; Aortic/venous thrombosis events, such as cerebrovascular
accidents (including transient ischemic attacks), deep vein thrombosis, and
pulmonary embolism, occurred within 6 months prior to initial administration;
Treatment with low molecular weight heparin was permitted and antiplatelet
drugs were prohibited throughout the study period;
5. Active viral hepatitis with poor control;
6. There is a history of active tuberculosis, idiopathic pulmonary fibrosis,
institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring
treatment or active pneumonia with clinical symptoms;
7. Have a history of psychotropic drug abuse and can not quit or have mental
disorders;
8. People who are ready to undergo or have previously received allogeneic bone
marrow transplantation or solid organ transplantation;
9. Have a history of hepatic encephalopathy;
10. Currently on or recently used (within 7 days before the start of study
treatment) aspirin (>325 mg/ day (maximum antiplatelet dose) or dipyridamole,
ticlopidine, clopidogrel, and cilostazol;
11. Subjects with any severe and/or uncontrolled disease.
- Tumor related and treatment:
1. For subjects who have received chemotherapy, immunotherapy within 3 weeks
before the first dose, radiation therapy or small molecule targeted drugs
within 2 weeks, or who are still within the 5 half-lives of the drug (as the
shortest time of occurrence), the washout period is calculated from the end
time of the last treatment;
2. Within 2 weeks before the first use of the drug, the treatment of Chinese
patent drugs with anti-tumor indications specified in the National Medical
Products Administration (NMPA) approved drug instructions;
3. Imaging including computed tomography (CT) or magnetic resonance imaging (MRI)
shows that the tumor has invaded important blood vessels, or the investigator
determines that the tumor is highly likely to invade important blood vessels
during the follow-up study period and cause fatal massive bleeding;
4. Uncontrolled pleural effusion, pericardial effusion or moderate to severe
ascites that still require repeated drainage;
5. Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of
normal (ULN) after endoscopic stent placement and percutaneous transhepatic
biliary drainage);
6. Known spinal cord compression, cancerous meningitis, with symptoms of brain
metastases, or symptoms controlled for less than 4 weeks.
- Research treatment related:
1. Known allergy to study drug excipients;
2. Have previously received anti-HER2 therapy drugs (only for the second stage,
the first stage is not limited);
3. Patients who require immunosuppressive, systemic, or absorbable topical hormone
therapy for immunosuppressive purposes and who continue to use it for 7 days
prior to initial administration (except for corticosteroids <10 mg per day of
prednisone or other therapeutic hormones).
4. Participants who participated in and used other anti-tumor clinical trials
within 4 weeks before the first medication.
5. According to the judgment of the researcher, there is a situation that
seriously endangers the safety of the subjects or affects the completion of the
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fuyang Cancer Hospital
Address:
City:
Fuyang
Zip:
236010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hesheng Qian, Bachelor
Phone:
13956814015
Email:
qianhesheng@sohu.com
Facility:
Name:
Anhui Second People's Hospital
Address:
City:
Hefei
Zip:
230012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhanggui Wang, Doctor
Phone:
13637095096
Email:
wzg79@zju.edu.cn
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yifu He, Doctor
Phone:
18963789042
Email:
834638033@qq.com
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yongkun Sun, Doctor
Phone:
13141276041
Email:
hsunyk@126.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100089
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun Zhou, Doctor
Phone:
13366152815
Email:
13366152815@126.com
Facility:
Name:
Tsinghua Changgeng Hospital, Beijing
Address:
City:
Beijing
Zip:
100089
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ming Yang, Doctor
Phone:
15810092973
Email:
ymicecream@163.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Xu, Doctor
Phone:
13527656798
Email:
xuli@sysucc.org.cn
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Gengsheng Yu, Doctor
Phone:
13828077428
Email:
gengsheng_yu@hotmail.com
Facility:
Name:
Tangshan People's Hospital
Address:
City:
Tangshan
Zip:
063000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiwu Wang, Doctor
Phone:
18931506162
Email:
tcm2000@163.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiwei Li
Phone:
15004683651
Email:
lzhw0451@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
YanRu Qin, Doctor
Phone:
13676932999
Email:
yanruqin@163.com
Facility:
Name:
Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430023
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hong Ma, Doctor
Phone:
13377876066
Email:
Wudajianzhu2004@163.com
Facility:
Name:
Wuhan University Zhongnan Hospital
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fuxiang Zhou, Doctor
Phone:
18971252780
Email:
happyzfx@sina.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jia Luo, Doctor
Phone:
13874994359
Email:
luojia@hnca.org.cn
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaofeng Chen, Doctor
Phone:
13585172066
Email:
Xiaofengch198019@126.com
Facility:
Name:
Dongtai People'S Hospital
Address:
City:
Yancheng
Zip:
224200
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qi Li, Doctor
Phone:
13818207333
Email:
leeqi2001@hotmail.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Cheng, Doctor
Phone:
0431-85871902
Email:
jl.cheng@163.com
Facility:
Name:
Chifeng City Hospital
Address:
City:
Chifeng
Zip:
024000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhonghua Liu, Doctor
Phone:
18604769266
Email:
M18047660067@163.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aili Suo, Doctor
Phone:
18991232561
Email:
ailisuo@mail.xjtu.edu.cn
Facility:
Name:
Shanghai Seventh People's Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Tingsong Chen, Master
Phone:
13601657441
Email:
cts552052597@163.com
Facility:
Name:
The Third Affiliated Hospital of PLA Navy Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Shen, Doctor
Phone:
13901651428
Email:
shenfengehbh@sina.com
Contact backup:
Last name:
Leilei Bao, Doctor
Phone:
021-81875571
Email:
annabao212@126.com
Facility:
Name:
First Hospital of Shangxi Medical University
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yusheng Wang, Doctor
Phone:
13834646436
Email:
wangyusheng1972@163.com
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongli Li, Doctor
Phone:
18622221233
Email:
hongli@126.com
Start date:
July 2024
Completion date:
December 2025
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/NCT06431490
