This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan
(T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally
advanced, unresectable, or metastatic colorectal cancer (mCRC).
This 2-stage study will evaluate participants with locally advanced, unresectable, or
metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC
2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF)
wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor
type, previously treated with standard therapy. In the first stage, participants will be
randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further
eligible participants will be registered to T-DXd administered IV 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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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