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
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
1 other identifier
interventional
204
1 country
39
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 ± chemotherapy in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2024
Typical duration for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2024
CompletedFirst Submitted
Initial submission to the registry
January 6, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
July 30, 2025
August 1, 2024
1.8 years
January 6, 2025
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
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 Outcomes (4)
Progression-free survival (PFS)
Baseline up to disease progression or die, an average of 3 year
Duration of Response (DOR)
Through study completion, an average of 1 year
Overall survival(OS)
Baseline up to die, an average of 3 year
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Baseline up to 28 days after the last dose
Study Arms (3)
TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy
EXPERIMENTALTQB2102 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
TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy
EXPERIMENTALTQB2102 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 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy
EXPERIMENTALTQB2102 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.
Interventions
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody
TQB2102 for injection is an antibody-coupled drug
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Fuyang Cancer Hospital
Fuyang, Anhui, 23600, China
Lu'an People's Hospital
Lu'an, Anhui, 237000, China
Maanshan People's Hospital
Maanshan, Anhui, 243000, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The first affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, 400016, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Gansu Prouincial Cancer Hospital
Lanzhou, Gansu, 730000, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733099, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541004, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
The first affiliated hospital of hainan medical university
Haikou, Hainan, 570102, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010, China
Tangshan People's Hospital
Tangshan, Hebei, 063001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
The 1st Affiliated Hospital of He'nan University of Science and Technology
Luoyang, Henan, 471000, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410000, China
NanJing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Jiangning Hospital of Nanjing City
Nanjing, Jiangsu, 211100, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225009, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 264000, China
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200120, China
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710000, China
Nanchong Central Hospital
Nanchong, Sichuan, 637000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202, China
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, 810000, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2025
First Posted
January 10, 2025
Study Start
November 21, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
July 30, 2025
Record last verified: 2024-08