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).
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
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
Parallel
TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection
DrugTQB2930 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 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)
DrugTQB2930 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.
Recommended Phase 2 Dose
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)
Incidence and severity of adverse events.
Objective Response Rate
The proportion of participants achieving complete response and partial response among the total evaluable cases.
Half-life
The time it takes for the concentration of a drug in the body (usually the plasma concentration) to decrease to half of its initial value.
Plasma concentration-time profiles
Total area covered under the curve plotted with time as X-axis and plasma concentration as Y-axis.
Apparent clearance
The rate at which the drug is cleared from the body.
Apparent terminal volume of distribution
Describe the drug distribution in the body.
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