Biliary Tract CancerPhase 1/2NCT06431490
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
A Phase 1/2 study testing TQB2102 for injection in people with Biliary Tract Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 43 sites in China.
Trial summary
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- TQB2102 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 43 sitesChina
- Study dates
- 22 Jul 2024to Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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;
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- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage;
- Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage);
- Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks.
- Research treatment related:
- Known allergy to study drug excipients;
- Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited);
- 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).
- Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication.
- 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.
Trial locations and contacts
43 sites in 1 country. Contact the study team or a site near you to ask about taking part.
43 sites in 1 country
China43 sites, 43 recruiting
- Not yet recruiting
AnYang Tumor Hospital
Anyang, Henan, 455000
Donghai Cui, Master, 18738285828, 18738285828@163.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Yongkun Sun, Doctor, 13141276041, hsunyk@126.com
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100089
Jun Zhou, Doctor, 13366152815, 13366152815@126.com
- Not yet recruiting
Tsinghua Changgeng Hospital, Beijing
Beijing, Beijing Municipality, 100089
Ming Yang, Doctor, 15810092973, ymicecream@163.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Haifeng Liu, Doctor, 0431-85871902, jl.cheng@163.com
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Huaxin Duan, Doctor, 13347315509, 317102912@qq.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Jia Luo, Doctor, 13874994359, luojia@hnca.org.cn
Yi He, Doctor, 18692237222, heyi@hnca.org.cn
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Qing Zhu, Doctor, 18009252290, newzhuging1972@163.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Hao Liu, Doctor, 19984265650, 604083933@qq.com
- Not yet recruiting
Chifeng City Hospital
Chifeng, Neimengu, 024000
Zhonghua Liu, Doctor, 18604769266, M18047660067@163.com
- Not yet recruiting
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Yong Chen, Doctor, 13883001073, doctorcy007@163.com
- Not yet recruiting
Fuyang Cancer Hospital
Fuyang, Anhui, 236010
Hesheng Qian, Bachelor, 13956814015, qianhesheng@sohu.com
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Zhuting Fang, Doctor, 13805012709, 470389481@qq.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510062
Li Xu, Doctor, 13527656798, xuli@sysucc.org.cn
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Chan Xie, Doctor, 13434383329, happyxiechan@hotmail.com
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Yaozhen Pan, Doctor, 18984389506, panyaozhen112@163.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310016
Qi Zhao, Doctor, 15205813046, hzxuqi@sina.cn
- Not yet recruiting
Zhejiang University Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Hong Yu, Doctor, 13605705907, blueyu000@zju.edu.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Zhiwei Li, 15004683651, lzhw0451@163.com
- Not yet recruiting
Anhui Second People's Hospital
Hefei, Anhui, 230012
Zhanggui Wang, Doctor, 13637095096, wzg79@zju.edu.cn
- Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Yifu He, Doctor, 18963789042, 834638033@qq.com
- Not yet recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Gengsheng Yu, Doctor, 13828077428, gengsheng_yu@hotmail.com
- Not yet recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Jin Jiang, Bachelor, 13736473903, 13208253@qq.com
- Not yet recruiting
Cancer Hospital of Shan dong First Medical University
Jinan, Shandong, 250000
He Tian, Bachelor, 13608920499, tianhejn@sina.com
- Not yet recruiting
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050
Zhihu Li, Master, 18993042850, 245698692@qq.com
- Not yet recruiting
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000
Hongxian Yan, Master, 15837197895, 15837197895@139.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yuling Guo, Master, 13907915109, 13907915109@139.com
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Xiaofeng Sun, Master, 13505156959, jssxfgcp@163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Xiaofeng Chen, Doctor, 13585172066, Xiaofengch198019@126.com
- Not yet recruiting
Guangxi University Affiliated Hospital
Nanning, Guangxi, 530220
Yumei Zhang, Master, 13617716921, Zhzm05@163.com
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Maolan Li, Doctor, 13564694193, limaolan6@163.com
- Recruiting
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality, 200433
Tingsong Chen, Master, 13601657441, cts552052597@163.com
- Recruiting
The Third Affiliated Hospital of PLA Navy Medical University
Shanghai, Shanghai Municipality, 200433
Feng Shen, Doctor, 13901651428, shenfengehbh@sina.com
Leilei Bao, Doctor, 021-81875571, annabao212@126.com
- Not yet recruiting
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, 030001
Yusheng Wang, Doctor, 13834646436, wangyusheng1972@163.com
- Not yet recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063000
Zhiwu Wang, Doctor, 18931506162, tcm2000@163.com
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000
Hongli Li, Doctor, 18622221233, hongli@126.com
- Not yet recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Hong Ma, Doctor, 13377876066, Wudajianzhu2004@163.com
- Not yet recruiting
Wuhan University Zhongnan Hospital
Wuhan, Hubei, 430071
Fuxiang Zhou, Doctor, 18971252780, happyzfx@sina.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Aili Suo, Doctor, 18991232561, ailisuo@mail.xjtu.edu.cn
- Not yet recruiting
Dongtai People'S Hospital
Yancheng, Jiangsu, 224200
Qi Li, Doctor, 13818207333, leeqi2001@hotmail.com
- Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443000
Cui Chen, Master, 13972003797, 79146460@qq.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
YanRu Qin, Doctor, 13676932999, yanruqin@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Jiamei Yang, Master, 13613863516, yjm6601@163.com
About this study
Official title: 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
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
- Conditions
- Biliary Tract Cancer
- Being tested
- TQB2102 for injection
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 for injectionDrug
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for injection | Experimental | Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles. Receives: Drug: TQB2102 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Baseline up to 24 weeks
Secondary outcomes (5)
Objective response rate (ORR)
The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Measured: Baseline up to 36 weeks
Progression-free survival (PFS)
The time between first medication and first disease progression or death from any cause.
Measured: Baseline up to 36 weeks
Disease control rate (DCR)
The first assessment was complete response, partial response, and time to disease stabilization.
Measured: Baseline up to 36 weeks
Disease response time (DOR)
First assessed as complete or partial response to first disease progression or time of death from all causes.
Measured: Baseline up to 36 weeks
Overall survival (OS)
Time from first use to death from any cause
Measured: Baseline up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start22 Jul 2024
- Primary completionMay 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431490
- Sponsor's protocol ID
- TQB2102-Ib/II-01
- Status last verified
- Dec 2025
- First submitted
- 22 May 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06431490
- Acronym / sponsor ID
- TQB2102-Ib/II-01
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2102 for injection | Experimental | Drug: TQB2102 for injectionIntravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 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:
- 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;
Key exclusion criteria (25 listed)
- Complicated diseases and medical history:
- Tumor related and treatment:
- Research treatment related:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2102 for injectionTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC) | Drug | TQB2102 for injection |
Primary outcome
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy
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).
Phase II Recommended Dose (RP2D)
Time frame: Baseline up to 24 weeks
Phase II Recommended Dose (RP2D)
5 secondary outcomes
Objective response rate (ORR)
Time frame: Baseline up to 36 weeks
Progression-free survival (PFS)
Time frame: Baseline up to 36 weeks
Disease control rate (DCR)
Time frame: Baseline up to 36 weeks
Disease response time (DOR)
Time frame: Baseline up to 36 weeks
Overall survival (OS)
Time frame: Baseline up to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2102 for injection in people with Biliary Tract Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 43 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Shen, Doctor (13901651428, shenfengehbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE) and serious adverse events (SAE) (time frame: From the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.