New hope for bile duct cancer: experimental drug targets HER2
NCT ID NCT06431490
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called TQB2102 in people with advanced bile duct cancer that has a specific marker (HER2-positive). The goal is to see if the drug can shrink tumors or slow the cancer's growth. About 102 adults aged 18 to 75 with good organ function are being recruited. The treatment is given by injection, and researchers will monitor side effects and how well the cancer responds.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 102 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 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 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
43 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AnYang Tumor Hospital
NOT_YET_RECRUITINGAnyang, Henan, 455000, China
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Anhui Provincial Cancer Hospital
NOT_YET_RECRUITINGHefei, Anhui, 230031, China
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Anhui Second People's Hospital
NOT_YET_RECRUITINGHefei, Anhui, 230012, China
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Beijing Cancer Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100089, China
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Cancer Hospital Chinese Academy of Medical Science
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100021, China
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Cancer Hospital of Shan dong First Medical University
NOT_YET_RECRUITINGJinan, Shandong, 250000, China
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Chifeng City Hospital
NOT_YET_RECRUITINGChifeng, Neimengu, 024000, China
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Dongtai People'S Hospital
NOT_YET_RECRUITINGYancheng, Jiangsu, 224200, China
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First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400010, China
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First Hospital of Shangxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030001, China
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Fujian Provincial Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350000, China
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Fuyang Cancer Hospital
NOT_YET_RECRUITINGFuyang, Anhui, 236010, China
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Gansu Provincial Tumor Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730050, China
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Guangxi University Affiliated Hospital
NOT_YET_RECRUITINGNanning, Guangxi, 530220, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430023, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410031, China
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Hunan Provincial People's Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410005, China
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Jiangmen Central Hospital
NOT_YET_RECRUITINGJiangmen, Guangdong, 529000, China
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Jiangsu Cancer Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Jiangsu Provincial People's Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Jilin Cancer Hospital
NOT_YET_RECRUITINGChangchun, Jilin, 130012, China
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Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
NOT_YET_RECRUITINGLuoyang, Henan, 471000, China
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Renji Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200127, China
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Shanghai Seventh People's Hospital
RECRUITINGShanghai, Shanghai Municipality, 200433, China
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Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610072, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510062, China
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Tangshan People's Hospital
NOT_YET_RECRUITINGTangshan, Hebei, 063000, China
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The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITINGGuiyang, Guizhou, 550000, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
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The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi'an, Shaanxi, 710000, China
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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The First Hospital of Jiaxing
NOT_YET_RECRUITINGJiaxing, Zhejiang, 314000, China
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The Second Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450014, China
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The Third Affiliated Hospital of PLA Navy Medical University
RECRUITINGShanghai, Shanghai Municipality, 200433, China
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The Third Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510630, China
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Tianjin Cancer Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300000, China
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Tsinghua Changgeng Hospital, Beijing
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100089, China
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West China Hospital of Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, 610041, China
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Wuhan University Zhongnan Hospital
NOT_YET_RECRUITINGWuhan, Hubei, 430071, China
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Yichang Central People's Hospital
NOT_YET_RECRUITINGYichang, Hubei, 443000, China
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Zhejiang Cancer Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310016, China
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Zhejiang University Run Run Shaw Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310016, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Second try: pumping chemo straight into the liver for tumors that outsmarted standard treatment
- Immunotherapy meets chemo: a new front against bile duct cancer
- Can a Three-Drug chemo cocktail before surgery stop biliary tract cancer from coming back?
- Can a new drug shrink advanced solid tumors?
- Can adding immunotherapy to standard cancer care be safe for indian patients?
- App-based symptom tracking may cut hospital visits for advanced cancer patients