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A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)
Daiichi Sankyo Ltd.
This is a randomised trial with two experimental stages. In Stage 1, participants will be randomised 1:1 with two doses of Trastuzumab deruxtecan (T-DXd): T-DXd 5.4 mg/kg Q3W intravenously every three weeks, and T-DXd 6.4 mg/kg Q3Q intravenously every three weeks. After stage 1 enrolment is complete, all further eligible participants will be registered to T-DXd administered intravenously in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.