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Also known as MT201
Adecatumumab · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Adecatumumab alone |
| 2 | EXPERIMENTAL | FOLFOX 4 followed by Adecatumumab |
| 3 | ACTIVE_COMPARATOR | FOLFOX 4 alone |
| Name | Type | Description |
|---|---|---|
| Adecatumumab | DRUG | Adecatumumab,6-9mg/kg, every 14 days, 24 cycles |
| Adecatumumab and FOLFOX | DRUG | FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles |
| FOLFOX 4 | DRUG | FOLFOX 4, every 14 days, 12 cycles |
Inclusion Criteria: * Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma * Age ≥18 years * ECOG performance status ≤ 2 * Patient was informed, has read and understood the patient information / informed consent form and has given written informed...
Adecatumumab was studied in oncology for liver metastases, specifically in patients with colorectal cancer who had undergone R0 resection of colorectal liver metastases. It is an investigational monoclonal antibody and is not an approved therapy. Its clinical evaluation focused on this adjuvant setting after surgical removal of liver metastases.
Adecatumumab targets EPCAM, the epithelial cell adhesion molecule. It is a monoclonal antibody that acts as an inhibitor of this target. EPCAM is a cell surface antigen expressed on epithelial cells and epithelial-derived tumors, which is why the compound was evaluated in colorectal cancer and liver metastases.
Adecatumumab is being developed by Amgen Inc., the biotechnology and pharmaceutical company traded on Nasdaq under the ticker AMGN. Amgen holds the asset, which is an investigational monoclonal antibody in oncology. The program has been studied in colorectal cancer patients with liver metastases.
Adecatumumab is in Phase 2 development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 2 study in colorectal liver metastases has been completed, and no active trials are currently listed for this asset.
Adecatumumab has been evaluated in one Phase 2 trial, NCT00866944, titled Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases. The trial enrolled 35 patients, was randomized and active controlled, and was conducted in France and Germany. It is now completed.
The Phase 2 trial NCT00866944 was a randomized, active-controlled study comparing adecatumumab with FOLFOX after R0 resection of colorectal liver metastases. It enrolled 35 patients aged 18 years and older of all sexes, took place in France and Germany, and did not use biomarker selection. The study is completed.