A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer

April 2, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China, 236010
        • Not yet recruiting
        • Fuyang Cancer Hospital
        • Contact:
      • Hefei, Anhui, China, 230031
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
      • Hefei, Anhui, China, 230012
        • Not yet recruiting
        • Anhui Second People's Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Science
        • Contact:
      • Beijing, Beijing Municipality, China, 100089
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100089
        • Not yet recruiting
        • Tsinghua Changgeng Hospital, Beijing
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Not yet recruiting
        • First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Provincial Tumor Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Not yet recruiting
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510062
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Jiangmen, Guangdong, China, 529000
        • Not yet recruiting
        • Jiangmen Central Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530220
        • Not yet recruiting
        • Guangxi University Affiliated Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Not yet recruiting
        • Tangshan People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin medical university cancer hospital
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • AnYang Tumor Hospital
        • Contact:
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
      • Zhengzhou, Henan, China, 450014
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Not yet recruiting
        • Wuhan University Zhongnan Hospital
        • Contact:
      • Wuhan, Hubei, China, 430023
        • Not yet recruiting
        • Huazhong University of Science and Technology
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Yichang Central People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Contact:
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
      • Yancheng, Jiangsu, China, 224200
        • Not yet recruiting
        • Dongtai People'S Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Neimengu
      • Chifeng, Neimengu, China, 024000
        • Not yet recruiting
        • Chifeng City Hospital
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Cancer Hospital of Shan dong First Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Seventh People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • The Third Affiliated Hospital of PLA Navy Medical University
        • Contact:
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200127
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • First Hospital of Shangxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Not yet recruiting
        • Tianjin cancer hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310016
        • Not yet recruiting
        • Zhejiang University Run Run Shaw Hospital
        • Contact:
      • Jiaxing, Zhejiang, China, 314000
        • Not yet recruiting
        • The First Hospital of Jiaxing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2102 for injection
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles.
Drug: TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
Time Frame: Baseline up to 24 weeks
Phase II Recommended Dose (RP2D)
Baseline up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Baseline up to 36 weeks
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.
Baseline up to 36 weeks
Progression-free survival (PFS)
Time Frame: Baseline up to 36 weeks
The time between first medication and first disease progression or death from any cause.
Baseline up to 36 weeks
Disease control rate (DCR)
Time Frame: Baseline up to 36 weeks
The first assessment was complete response, partial response, and time to disease stabilization.
Baseline up to 36 weeks
Disease response time (DOR)
Time Frame: Baseline up to 36 weeks
First assessed as complete or partial response to first disease progression or time of death from all causes.
Baseline up to 36 weeks
Overall survival (OS)
Time Frame: Baseline up to 36 weeks
Time from first use to death from any cause
Baseline up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2102-Ib/II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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