A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
NCT ID: NCT06431490
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
103 participants
INTERVENTIONAL
2024-07-22
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TQB2102 for injection
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles.
TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Interventions
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TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fuyang Cancer Hospital
Fuyang, Anhui, China
Anhui Second People's Hospital
Hefei, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Tsinghua Changgeng Hospital, Beijing
Beijing, Beijing Municipality, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Guangxi University Affiliated Hospital
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Tangshan People's Hospital
Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
AnYang Tumor Hospital
Anyang, Henan, China
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan University Zhongnan Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Dongtai People'S Hospital
Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Chifeng City Hospital
Chifeng, Neimengu, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Cancer Hospital of Shan dong First Medical University
Jinan, Shandong, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality, China
The Third Affiliated Hospital of PLA Navy Medical University
Shanghai, Shanghai Municipality, China
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang University Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB2102-Ib/II-01
Identifier Type: -
Identifier Source: org_study_id
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