Condition: Advanced Small Bowel Adenocarcinoma · Sponsor: National Cancer Center, Japan
Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, there is no widely accepted standard second-line therapy, and outcomes are generally poor. New treatment options are therefore urgently needed. Recent retrospective research from our group has shown that the majority of the small bowel adenocarcinomas strongly express a protein called Nectin-4 on the surface of cancer cells. High Nectin-4 expression was also associated with poorer survival, suggesting that Nectin-4 could be a crucial treatment target in this disease. Enfortumab vedotin is a targeted anticancer drug called an antibody-drug conjugate. It combines an antibody that recognizes Nectin-4 with vedotin, a cytotoxic anticancer agent (payload). After enfortumab vedotin binds to Nectin-4 on the tumor cell surface, it is taken up into the cell and releases the anticancer payload, which damages the cell's internal structure and leads to cell death and apoptosis. Enfortumab vedotin has already shown meaningful antitumor activity and an acceptable safety profile in patients with advanced urothelial carcinoma and is approved over the world. However, its efficacy has never been formally evaluated in patients with small bowel adenocarcinoma. ENVELOPE is a multicent…
This description comes directly from the study's public registry record.
Ken Kato, M.D., Ph.D. · +81.3.3542.2511 · kenkato@ncc.go.jp
Hiroyuki Fujii, M.D., Ph.D. · +81.3.3542.2511 · hifuj2@ncc.go.jp
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| Kyushu University Hospital | Fukuoka, Japan | Recruiting |
| Osaka International Cancer Institute | Osaka, Japan | Recruiting |
| National Cancer Center Hospital | Tokyo, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07347314