A Phase I, Dose Escalation Study of BNC101 in Patients With Metastatic Colorectal Cancer.

The purpose of this study is to determine the maximum tolerated dose (which will be the dose recommended for a Phase 2 study), safety, tolerability and pharmacokinetic profile (study of movement of the drug within the body, including absorption and distribution) of the study drug, BNC101 when administered intravenously as a single agent or in combination with chemotherapy in patients with metastatic colorectal cancer who have failed at least 1 or 2 lines of chemotherapy.

本研究旨在明确研究药物BNC101的最大耐受剂量（maximum tolerated dose，即推荐用于II期研究的剂量）、安全性、耐受性与药代动力学特征（pharmacokinetic profile，即研究药物在体内的运动过程，包括吸收与分布）；该药物将以单药或联合化疗的静脉给药方式，应用于至少经1或2线化疗失败的转移性结直肠癌患者。