A Clinical Trial Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Patients With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
71 participants
Sep 3, 2026
INTERVENTIONAL
Conditions
Summary
To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in sparticipants with HER2-Abnormally Expressed locally advanced or metastatic colorectal cancer (CRC).
Eligibility
Inclusion Criteria8
- Participants 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-Abnormally Expressed tested
- Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Participants should agree to use contraception during the study and for 6 months after the end
Exclusion Criteria20
- Participants 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
- Participants 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 participants' safety or affect the completion of the study, or the participant is considered unsuitable for other reasons
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Interventions
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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks VEGF binding to receptors and inhibits tumor angiogenesis.
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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.
Locations(31)
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NCT07653685