Actively Recruiting
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
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-04-08
102
Participants Needed
43
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of TQB2102 for injection in patients with HER2-positive biliary tract cancer. This includes patients with locally advanced or metastatic forms of the disease who have experienced failure of 1-2 prior systemic therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. and spans phases 1 and 2 to evaluate dosing, safety, and immune response. Participants receive TQB2102, a HER2 dual-antibody-drug conjugate, by intravenous infusion every three weeks in cycles of 21 days. Treatment involves 6 to 8 cycles, with ongoing monitoring for adverse events and response to therapy. The study does not use masking or placebo controls. During the trial, participants undergo assessments for tumor response, disease control, survival, and side effects from the time of consent until 28 days after the last dose or the start of a new antitumor therapy. Follow-up includes evaluations up to 36 weeks for outcomes like progression-free and overall survival. Participants also provide tumor tissue samples for HER2 testing and are monitored for immune reactions and safety throughout the study.
CONDITIONS
Brief Title
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years with ECOG score 0 to 1
- Confirmed HER2-positive biliary tract cancer by tumor tissue test (IHC 3+ or IHC 2+ with ISH positive)
- Adequate main organ function
- Locally advanced, recurrent, or metastatic biliary tract carcinoma confirmed by histology or cytology
- At least one measurable lesion per RECIST 1.1 criteria
- Failure of 1-2 prior systemic therapy lines
- Women of reproductive age agree to use effective contraception during study and for 6 months after
- Men agree to use effective birth control during study and for 6 months after
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Other malignant tumors within 3 years before first medication
- Unresolved toxic effects higher than grade 1 from prior treatments
- Major surgery, significant injury, or unhealed wounds/fractures within 4 weeks before medication
- Bleeding events grade 3 or higher within 4 weeks before first dose
- Recent thrombosis events within 6 months prior to treatment
- Active viral hepatitis poorly controlled
- History or presence of serious lung diseases or active pneumonia
- History of psychotropic drug abuse or mental disorders
- Previous allogeneic bone marrow or solid organ transplant
- History of hepatic encephalopathy
- Recent use of certain anticoagulant or antiplatelet drugs
- Severe or uncontrolled diseases
- Recent chemotherapy, immunotherapy, radiation, or targeted drugs within specified washout periods
- Recent use of antitumor Chinese patent drugs within 2 weeks
- Tumor invasion of important blood vessels or risk of fatal bleeding
- Uncontrolled pleural, pericardial effusion, or moderate-severe ascites
- Obvious biliary obstruction except controlled cases
- Known spinal cord compression, cancer meningitis, or brain metastases with recent symptoms
- Allergy to study drug components
- Prior anti-HER2 therapy for phase 2 participants
- Use of immunosuppressive therapies except low-dose corticosteroids
- Participation in other anti-tumor clinical trials within 4 weeks
- Any condition seriously endangering safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 cycles of 21 days each
Participants receive TQB2102 for injection by intravenous infusion every 3 weeks as a treatment cycle.
Every 3 weeks for 6 to 8 treatment cycles
Duration - 28 days after the last dose
Participants are monitored for safety and efficacy after the last dose or start of new antitumor therapy.
Approximately 1 follow-up visit
Trial Site Locations
Total: 43 locations
1
Fuyang Cancer Hospital
Fuyang, Anhui, China, 236010
Not Yet Recruiting
2
Anhui Second People's Hospital
Hefei, Anhui, China, 230012
Not Yet Recruiting
3
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Not Yet Recruiting
4
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100089
Not Yet Recruiting
6
Tsinghua Changgeng Hospital, Beijing
Beijing, Beijing Municipality, China, 100089
Not Yet Recruiting
7
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
8
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
9
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
10
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510062
Not Yet Recruiting
11
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Not Yet Recruiting
12
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
13
Guangxi University Affiliated Hospital
Nanning, Guangxi, China, 530220
Not Yet Recruiting
14
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
Not Yet Recruiting
15
Tangshan People's Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
16
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
17
AnYang Tumor Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
18
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China, 471000
Not Yet Recruiting
19
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
20
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
Not Yet Recruiting
21
Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Not Yet Recruiting
22
Wuhan University Zhongnan Hospital
Wuhan, Hubei, China, 430071
Not Yet Recruiting
23
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Not Yet Recruiting
24
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Not Yet Recruiting
25
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
26
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
27
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
28
Dongtai People'S Hospital
Yancheng, Jiangsu, China, 224200
Not Yet Recruiting
29
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
30
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
31
Chifeng City Hospital
Chifeng, Neimengu, China, 024000
Not Yet Recruiting
32
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
33
Cancer Hospital of Shan dong First Medical University
Jinan, Shandong, China, 250000
Not Yet Recruiting
34
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Not Yet Recruiting
35
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
36
The Third Affiliated Hospital of PLA Navy Medical University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
37
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
38
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
39
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
40
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
41
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
42
Zhejiang University Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
43
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China, 314000
Not Yet Recruiting
Research Team
F
Feng Shen, Doctor
J
Jun Zhou, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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