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
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2024-11-21
Last updated
2025-07-30
Condition(s) studied
Gastroesophageal Adenocarcinoma
Investigational drug(s) / intervention(s)
TQB2102 for injection (7.5 mg) +Benmelstobart+ChemotherapyTQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+ChemotherapyTQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy
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
TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy: TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody
TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy: TQB2102 for injection is an antibody-coupled drug
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate (ORR) — 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.
Trial sites (39)
Facility
City
Region
Status
Fuyang Cancer Hospital
Fuyang
Anhui
Not Yet Recruiting
Lu'an People's Hospital
Lu'an
Anhui
Not Yet Recruiting
Maanshan People's Hospital
Maanshan
Anhui
Recruiting
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
The first affiliated hospital of chongqing medical university
Chongqing
Chongqing Municipality
Not Yet Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Not Yet Recruiting
Gansu Prouincial Cancer Hospital
Lanzhou
Gansu
Not Yet Recruiting
Gansu Wuwei Tumour Hospital
Wuwei
Gansu
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
Nanfang Hospital
Guangzhou
Guangdong
Not Yet Recruiting
Jiangmen Central Hospital
Jiangmen
Guangdong
Not Yet Recruiting
Meizhou People's Hospital
Meizhou
Guangdong
Not Yet Recruiting
The Second Affiliated Hospital of Guilin Medical College
Guilin
Guangxi
Not Yet Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Not Yet Recruiting
The first affiliated hospital of hainan medical university
Haikou
Hainan
Not Yet Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Not Yet Recruiting
Tangshan People's Hospital
Tangshan
Hebei
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Anyang Cancer Hospital
Anyang
Henan
Not Yet Recruiting
The 1st Affiliated Hospital of He'nan University of Science and Technology
Luoyang
Henan
Not Yet Recruiting
Puyang Oilfield General Hospital
Puyang
Henan
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
Xiangyang Central Hospital
Xiangyang
Hubei
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Not Yet Recruiting
The Second Xiangya Hospital Of Central South University
Changsha
Hunan
Not Yet Recruiting
NanJing Drum Tower Hospital
Nanjing
Jiangsu
Not Yet Recruiting
Jiangning Hospital of Nanjing City
Nanjing
Jiangsu
Not Yet Recruiting
Northern Jiangsu People's Hospital
Yangzhou
Jiangsu
Not Yet Recruiting
Jilin Cancer Hospital
Changchun
Jilin
Not Yet Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Not Yet Recruiting
Fudan university shanghai cancer center
Shanghai
Shanghai Municipality
Not Yet Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanxi Cancer hospital
Taiyuan
Shanxi
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an
Shanxi
Not Yet Recruiting
Nanchong Central Hospital
Nanchong
Sichuan
Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi
Xinjiang
Not Yet Recruiting
Wenzhou Medical University Affiliated First Hospital
Wenzhou
Zhejiang
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
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