Jiangsu HengRui Medicine Co., Ltd.
This global study is being conducted to evaluate the safety and determine the recommended phase 3 dose of trastuzumab rezetecan in combination with mFOLFOX6 chemotherapy (dose level -1) and bevacizumab as first-line treatment in participants with advanced colorectal cancer that expresses HER2, including but not limited to HER2 immunohistochemistry (IHC) 2+ "equivocal" or 3+ "positive" based on gastric cancer criteria, focused on the Western population. Encouraging data in efficacy and safety with trastuzumab rezetecan in a similar setting in China (NCT06015048) were presented at 2026 American Society of Clinical Oncology annual meeting.
Inclusion Criteria: 1. ECOG performance status score of 0 or 1. 2. Histologically or cytologically confirmed unresectable, recurrent, or metastatic colorectal adenocarcinoma that is HER2-positive. "HER2-positive" indicates IHC 2+ or 3+, or HER2 (ERBB2) amplification by NGS at a CLIA-certified or ISO-accredited laboratory. HER2 IHC 2+/3+ should be based on gastric cancer criteria. 3. Either have not received any prior systemic anti-tumor therapy (including, but not limited to, systemic chemotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, or other investigational agents), o…
Trastuzumab Rezetecan (SHR-A1811) injection; high dose
Trastuzumab Rezetecan (SHR-A1811) injection; low dose
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