A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma

July 28, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection in Chemotherapy With Behmosubstituted Monoclonalb/Pembrolizumab ± Chemotherapy in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma

TQB2102 for injection is a novel antibody-coupled drug (ADC) that enhances binding to tumor cell surface HER2 proteins by simultaneously targeting the two non-overlapping epitopes of the HER2 protein, Endothelial Cell Dysfunction 2 (ECD2) and Endothelial Cell Dysfunction 4 (ECD4), increasing HER2 internalization, and then down-regulating the tumor cell surface HER2 proteins more effectively, and doubly blocking the HER2 signaling, to achieve the effects of trastuzumab and Pertuzumab alone and in combination. This is a Phase II study to evaluate the efficacy and safety of TQB2102 for injection in combination with Benmelstobart Injection /Penpulimab Injection ± chemotherapy in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 2

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

  • Name: Ruihua Xu, Doctor
  • Phone Number: 86-20-87343468
  • Email: ruihxu@163.com

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China, 23600
        • Not yet recruiting
        • Fuyang Cancer Hospital
        • Contact:
      • Lu'an, Anhui, China, 237000
        • Not yet recruiting
        • Lu'an People's Hospital
        • Contact:
      • Maanshan, Anhui, China, 243000
        • Recruiting
        • Maanshan People's Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Gansu Prouincial Cancer Hospital
        • Contact:
        • Contact:
      • Wuwei, Gansu, China, 733099
        • Not yet recruiting
        • Gansu Wuwei Tumour Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Ruihua Xu, Doctor
          • Phone Number: 86-20-87343468
          • Email: ruihxu@163.com
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital
        • Contact:
      • Jiangmen, Guangdong, China, 529000
        • Not yet recruiting
        • Jiangmen Central Hospital
        • Contact:
      • Meizhou, Guangdong, China, 514031
        • Not yet recruiting
        • Meizhou People's hospital
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541004
        • Not yet recruiting
        • The Second Affiliated Hospital of Guilin Medical College
        • Contact:
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570102
        • Not yet recruiting
        • The First Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
      • Tangshan, Hebei, China, 063001
        • 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 Cancer Hospital
        • Contact:
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • The 1st Affiliated Hospital of He'nan University of Science and Technology
        • Contact:
      • Puyang, Henan, China, 457001
        • Not yet recruiting
        • Puyang Oilfield General Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangyang Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • The second Xiangya hospital of central south university
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 211100
        • Not yet recruiting
        • Jiangning Hospital of Nanjing City
        • Contact:
      • Yangzhou, Jiangsu, China, 225009
        • Not yet recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 264000
        • Not yet recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai, China, 200120
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Not yet recruiting
        • Nanchong Central Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300202
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Hongli Li, Doctor
          • Phone Number: 022-23340123-3252
          • Email: hongli@126.com
    • Xinjiang
      • Ürümqi, Xinjiang, China, 810000
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Cancer Hospital
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • Wenzhou Medical University Affiliated First Hospital
        • 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 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy≥3 months;
  • Histopathologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma;
  • HER2 expression levels of Immunohistochemistry(IHC) 3+ or IHC 2+ and In Situ Hybridization (ISH) positivity were confirmed in tumor tissue;
  • Subject is able to provide previous compliant PD-L1 expression level test results or is able to provide sufficient and competent tumor tissue for PD-L1 expression level testing;
  • Patients who have not received prior systemic therapy for locally advanced or metastatic gastric cancer and who have experienced tumor recurrence or metastasis at least 6 months after the completion of prior adjuvant or neoadjuvant therapy may be enrolled;
  • Confirmation of at least one measurable lesion according to RECIST 1.1 criteria;
  • The main organs function well;
  • Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

  • Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;
  • Uncontrollable toxic reactions above CTC AE grade 1 due to any prior therapy, excluding alopecia;
  • Major surgical treatment, incisional biopsy or significant traumatic injury or prolonged unhealed wound or fracture within 28 days prior to first dose;
  • Prior history of interstitial lung disease/pneumonia (non-infectious) requiring steroidal drug intervention or current concomitant (or suspected) interstitial lung disease/pneumonia;
  • Arterial/venous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, have occurred within 6 months prior to the first dose;
  • Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
  • Subjects with the presence of any severe and/or uncontrolled disease；
  • Subjects who have received other antitumor drugs such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, or who are still within the 5 half-life of the drug (whichever occurs shortest); have received a proprietary Chinese medicine with an antitumor indication as specified in the National Medical Products Administration(NMPA) -approved drug insert within 2 weeks prior to the first dose; and have experienced any hemorrhagic or bleeding event in the month prior to the initiation of study treatment ≥CTC Patients with AE grade 3;
  • Subjects with known Central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Presence of severe bone damage and spinal cord compression due to tumor bone metastases;
  • History of live attenuated vaccination within 28 days prior to the first dose or planned live attenuated vaccination during the study;
  • History of severe hypersensitivity reactions to large molecule drugs or hypersensitivity to known components of TQB2102, benmelstobart or pembrolizumab for injection;
  • Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the first dose of medication
  • Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy that was continued within 2 weeks prior to initiation of study treatment.
  • Participants who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication use
  • Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy

TQB2102 for Injection and bemarituzumab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days.

TQB2102 and bemosubicinumab for injection every three weeks and capecitabine Day1-Day15 administered orally in 21-day cycles
Drug: TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody
Experimental: TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy
TQB2102 for Injection and bemarituzumab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days.
Drug: TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody
Experimental: TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy
TQB2102 for Injection and Penpulimab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days.
Drug: TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy
TQB2102 for injection is an antibody-coupled drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Through study completion, an average of 1 year
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST )for solid tumors.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Baseline up to disease progression or die, an average of 3 year
Defined as the time from first use of TQB2102 to first disease progression or death from any cause
Baseline up to disease progression or die, an average of 3 year
Duration of Response (DOR)
Time Frame: Through study completion, an average of 1 year
Defined as the time from first documented response to documented disease progression or death
Through study completion, an average of 1 year
Overall survival(OS)
Time Frame: Baseline up to die, an average of 3 year
Overall survival refers to the time from the first treatment to death from any cause
Baseline up to die, an average of 3 year
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline up to 28 days after the last dose
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Baseline up to 28 days after the last dose

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)

November 21, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2102-II-04

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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