A Clinical Trial Evaluating TQB2102 for Injection in Combination With Benmelstobart/Penpulimab With or Without Capecitabine in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma
- Conditions
- Gastroesophageal Adenocarcinoma
- Interventions
- Drug: TQB2102 for injection+BenmelstobartDrug: TQB2102 for injection+Benmelstobart+Capecitabine
- Registration Number
- NCT06767800
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Brief 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 ± capecitabine in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 168
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQB2102 for injection+Benmelstobart TQB2102 for injection+Benmelstobart TQB2102 for injection in combination with benmelstobart every three weeks for a cycle of 21 days TQB2102 and bemosubicinumab for injection every three weeks and capecitabine Day1-Day15 administered orally in 21-day cycles TQB2102 for injection+Benmelstobart+Capecitabine TQB2102 for injection+Benmelstobart+Capecitabine TQB2102 and benmelstobart for injection every three weeks and capecitabine Day1-Day15 administered orally in 21-day cycles.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 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
Duration of Response (DOR) Through study completion, an average of 1 year Defined as the time from first documented response to documented disease progression or death
Overall survival(OS) Baseline up to die, an average of 3 year Overall survival refers to the time from the first treatment to death from any cause
Number of patients with adverse events (AEs) and serious adverse events (SAEs) Baseline up to 28 days after the last dose Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Trial Locations
- Locations (36)
Fuyang Cancer Hospital
🇨🇳Fuyang, Anhui, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The first affiliated hospital of chongqing medical university
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Gansu Prouincial Cancer Hospital
🇨🇳Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital
🇨🇳Wuwei, Gansu, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
Meizhou People's Hospital
🇨🇳Meizhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical College
🇨🇳Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
The first affiliated hospital of hainan medical university
🇨🇳Haikou, Hainan, China
Tangshan People's Hospital
🇨🇳Tangshan, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The 1st Affiliated Hospital of He'nan University of Science and Technology
🇨🇳Luoyang, Henan, China
Puyang Oilfield General Hospital
🇨🇳Puyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, Hunan, China
NanJing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Fudan university shanghai cancer center
🇨🇳Shanghai, Shanghai, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shanxi, China
Nanchong Central Hospital
🇨🇳Nanchong, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Xinjiang Medical University Affiliated Cancer Hospital
🇨🇳Ürümqi, Xinjiang, China
Wenzhou Medical University Affiliated First Hospital
🇨🇳Wenzhou, Zhejiang, China