Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)

Inclusion Criteria: * Signed written informed consent prior to enrollment； * Adults 18 years of age or older, male or female; * Histologically- or cytologically-confirmed CRC that is metastatic disease, and a) progression of disease or intolerance after line 1 or line 2 therapy，or inappropriate for line 1 therapy (for phase Ⅱa); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase Ⅱb); * Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1); * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Life expectancy ≥ 3 months; * Able to take the medicine orally; * Adequate bone marrow and organ function. Exclusion Criteria: * Prior treatment with any RAS inhibitors, RAF inhibitors, or MEK inhibitors; * History or screening evidence of retinal diseases; * Impaired cardiovascular function or clinically significant cardiovascular and cerebrovascular diseases; * Previous or current neuromuscular diseases that is associated with CK elevation (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome); * Impaired liver function, defined as Child-Pugh Class B or C; * Toxicity has not recovered to grade 0 or 1 from prior anticancer therapy (except for alopecia, pigmentation, and grade 2 chemotherapy-related neurotoxicity); * Use of any medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 within 7 days prior to the start of study treatment or during the study period, , drugs with a narrow therapeutic window for CYP1A2 metabolism.