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.