A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
1 other identifier
interventional
102
1 country
43
Brief Summary
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2024
Longer than P75 for phase_1
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedStudy Start
First participant enrolled
July 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
April 8, 2026
December 1, 2025
2.8 years
May 22, 2024
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever came first).
From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy
Phase II Recommended Dose (RP2D)
Phase II Recommended Dose (RP2D)
Baseline up to 24 weeks
Secondary Outcomes (5)
Objective response rate (ORR)
Baseline up to 36 weeks
Progression-free survival (PFS)
Baseline up to 36 weeks
Disease control rate (DCR)
Baseline up to 36 weeks
Disease response time (DOR)
Baseline up to 36 weeks
Overall survival (OS)
Baseline up to 36 weeks
Study Arms (1)
TQB2102 for injection
EXPERIMENTALIntravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles.
Interventions
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Eligibility Criteria
You may qualify if:
- years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
- Subjects must provide sufficient tumor tissue sample and confirm HER2 positivity by central laboratory prior to first dose, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH) positive;
- The main organs function well;
- Meet the criteria for advanced biliary tract cancer:
- Biliary tract carcinoma confirmed by histology or cytology;
- 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;
- Failure of 1-2 prior lines of systemic therapy
- 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.
You may not qualify if:
- Complicated diseases and medical history:
- Have had or are currently suffering from other malignant tumors within 3 years before the first medication;
- Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;
- Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication;
- 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;
- Active viral hepatitis with poor control;
- 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;
- Have a history of psychotropic drug abuse and can not quit or have mental disorders;
- People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;
- Have a history of hepatic encephalopathy;
- 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;
- Subjects with any severe and/or uncontrolled disease.
- Tumor related and treatment:
- 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;
- 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;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Fuyang Cancer Hospital
Fuyang, Anhui, 236010, China
Anhui Second People's Hospital
Hefei, Anhui, 230012, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100089, China
Tsinghua Changgeng Hospital, Beijing
Beijing, Beijing Municipality, 100089, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000, China
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510062, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Guangxi University Affiliated Hospital
Nanning, Guangxi, 530220, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
Tangshan People's Hospital
Tangshan, Hebei, 063000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
AnYang Tumor Hospital
Anyang, Henan, 455000, China
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Wuhan University Zhongnan Hospital
Wuhan, Hubei, 430071, China
Yichang Central People's Hospital
Yichang, Hubei, 443000, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000, China
Dongtai People'S Hospital
Yancheng, Jiangsu, 224200, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Chifeng City Hospital
Chifeng, Neimengu, 024000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
Cancer Hospital of Shan dong First Medical University
Jinan, Shandong, 250000, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality, 200433, China
The Third Affiliated Hospital of PLA Navy Medical University
Shanghai, Shanghai Municipality, 200433, China
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310016, China
Zhejiang University Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 28, 2024
Study Start
July 22, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
April 8, 2026
Record last verified: 2025-12