Memorial Sloan Kettering Cancer Center
The purpose of this study is find out whether the combination of trastuzumab deruxtecan (T-DXd) and cetuximab is an effective treatment for participants with metastatic and/or unresectable colorectal cancer that expresses low levels of HER2 and that has gotten worse after receiving standard treatment.
Inclusion Criteria: * Have histologically confirmed adenocarcinoma of the colon or rectum that is metastatic and/or unresectable. * Unless otherwise contraindicated, participants must have received regimens containing the following agents: fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan, and if the tumor is MSI-H/MMRd, a PD-(L)1 directed antibody. There is no maximum number of prior lines of therapy. * Prior anti-HER2 therapies other than T-DXd are allowed, with a washout period of at least 4 weeks. * Prior anti-EGFR therapies, including cetuximab, are allowed…
The investigational study drug, fam-trastuzumab deruxtecan-nxki (ENHERTU® ), consists of an antibody component, MAAL-9001, covalently conjugated via a maleimide tetrapeptide linker, to a drug component, MAAA-1181a.