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

This is a randomized, double-blind, placebo-controlled, dose-escalating, multi-center study to evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab and 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

1. Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Planned to receive FOLFOX with bevacizumab in the first-line palliative setting, including for patients with recurrences/progressive disease more than 180 days after postoperative adjuvant chemotherapy

Exclusion Criteria

1. Trauma that may increase the risk of bleeding or stroke within 90 days (3 months) prior to the planned Cycle 1 Day 1 2. History of pulmonary hemorrhage or GI hemorrhage (exceeding the typical presentation of mCRC) requiring transfusion, invasive intervention, or hospitalization within 90 days (3 months) prior to the planned Cycle 1 Day 1 unless a corrective interventional procedure has been performed (e.g., resection of primary tumor, therapeutic endoscopy) or there is evidence of complete resolution 3. Complete hemostasis not achieved after surgery or trauma 

Study Requirements

This study includes 2 parallel parts (Part A and Part B) which have 5 cohorts per part as shown in the schema (See Figure 1). Part B cohorts start one dosing step behind Part A cohorts. Subjects who meet eligibility criteria will be randomized to receive ART-123 or placebo with ratio of 3:1 at Cycle 1 Day 1. Subjects will receive investigational medical product (IMP) on Day 1 of each cycle before FOLFOX + bevacizumab administration until subjects receive 3 cycles including both IMP and bevacizumab, or a subject meets any of the criteria for discontinuation of IMP, whichever occurs first.