Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

Inclusion Criteria:

• 18 years of age or older
• Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
• ECOG performance status of 0 or 1
• The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
• Able to sufficiently understand the clinical study and give written informed consent

Exclusion Criteria:

• History of major hemorrhage
• High risk of hemorrhage
• History of other malignancies
• Active ulcer
• Patients using anti-coagulants and fibrinolytic drugs
• Active Hepatitis B, or known HBs antigen positive
• Prior treatment history with thrombomodulin alfa
• Administration of another investigational medicinal product within 30 days prior to randomization
• Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
• Patients otherwise deemed as inappropriate to participate in the study by the Investigator