TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection: TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks Vascular Endothelial Growth Factor (VEGF) binding to receptors and inhibits tumor angiogenesis.
TQB2930 injection + Oxaliplatin injection + Capecitabine tablets: TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting Extracellular Domain 2 (ECD2) and Extracellular Domain 4 (ECD4), two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.
Study summary
To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in subjects with HER2-positive unresectable locally advanced or metastatic colorectal cancer (CRC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance
* Age: 18-75 years (including the boundary when signing the informed consent form)
* Eastern Cooperative Oncology Group (ECOG) score: 0-1
* Expected survival of more than 3 months
* Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology
* HER2 positive tested
* Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Subjects should agree to use contraception during the study and for 6 months after the end
Exclusion Criteria:
* Patients with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR)
* Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications
* Active inflammatory bowel disease within 28 days prior to first dose
* Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies
* Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy
* Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment
* Had wounds or fractures that had not been healed for a long time
* Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose
* Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders
* Subjects with any severe and/or uncontrolled disease
* Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks
* Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study
* Failure to control serous effusions requiring repeated drainage
* Local radiotherapy or 4. Bone marrow irradiation \> 30% for bone metastasis before the first medication
* Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain
* Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication;
* Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment
* History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study;
* Previous history of severe allergy of unknown origin
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or the subject is considered unsuitable for other reasons
Primary outcome measure(s)
Recommended Phase 2 Dose — Baseline up to 21 days It refers to the safe and effective dose range that can be used for phase II study determined through phase I clinical trial.
Adverse event (AE) — From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first) Incidence and severity of adverse events.
Objective Response Rate — Baseline up to 24 months The proportion of patients achieving complete response and partial response among the total evaluable cases.
Trial sites (24)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Gansu Provincial Tumor Hospital
Lanzhou
Gansu
Guangxi Zhuang Autonomous Region Cancer Hospital
Nanning
Guangxi
The Affiliated Hospital of Zunyi Medical University
Zunyi
Guizhou
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Henan Cancer Hospital
Zhengzhou
Henan
The first affiliated hospital of Zhengzhou university
Zhengzhou
Henan
The Third People's Hospital of Zhengzhou
Zhengzhou
Henan
Jingzhou First People's Hospital
Jingzhou
Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Hunan Cancer Hospital
Changsha
Hunan
Jiangsu Provincial Cancer Hospital
Nanjing
Jiangsu
Zhongda Hospital Southeast University
Nanjing
Jiangsu
Jilin Cancer Hospital
Changchun
Jilin
The first hospital of Jilin University
Changchun
Jilin
Liaoning Cancer Hospital & Institute
Shenyang
Liaoning
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an
Shaanxi
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
The First Affiliated Hospital of Air Force Medical University
Xi’an
Shanxi
The Second Affiliated Hospital of Air Force Medical University
Xi’an
Shanxi
Tianjin Union Medical Center
Tianjin
Tianjin Municipality
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi
Xinjiang
Lishui Municipal Central Hospital
Lishui
Zhejiang
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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