A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer

Prior treatment

• Patients who received radiation therapy, chemotherapy or biological agent including hormone therapy recently.
• Subjects who had a surgery with general anesthesia within 4 weeks of screening.
• Subjects who had findings of affecting absorptin of the IP with gastrointestinal surgery or impossible oral drug administration.
• Hypersensitivity to the ingredient(s) of the investigational product (BEY 1107) or capecitabine, 5-FU (fluorouracil).
• Subjects who take a Rifampin and azole class antifungal drugs in combination.
• Subjects who had been administered other IP within 4 weeks prior to screening.

Other illness

• Subjects with systemic disease not suitable for anticancer agent administration at the discretion of the investigator.
• Subjects who had a cardiovascular disease as of screening.
• Subjects with history of malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ or papillary thyroid cancer appropriately treated within 5 years.
• Gastrointestinal bleeding or ulcer.
• HIV Positive.
• Ineligible result of HBV, HCV by the investigator.
• Acute or severe infection.

Lab values

• Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Subjects who take a combination of tegafur, gimeracil and oteracil potassium or discontinue within 7 days at the screening.

Other

• Subjects with symptomatic brain metastasis.
• Subjects with peripheral neuropathy.
• Dihydro-Pyridine Dehydrogenase (DPD) deficiency.
• Subjects who take a Sorivudine or brivudine in combination.
• Subjects who has labortory findings of inadequate bone marrow, kidney and liver function.
• Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
• Subjects with life expectancy of less than 12 weeks by the investigator.
• Subjects determined by the investigator to be ineligible for participation in this trial.

• Adult males and females aged over 19 years or older at the time of Informed Consent.
• Histopathologically or cytologically diagnosed with colorectal cancer.
• Patients with unresectable metastatic lesion(s).
• Patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy (including fluoropyrimidine, oxaliplatin and irinotecan).
• Subjects who have at least one measurable or evaluable lesion as per RECIST v1.1.
• Subjects with ECOG performance status 0 or 1.
• Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile.
• Non-vasectomized men who consent to use an acceptable contraception by one-self and the partner until 3 months after the end of IP administration.
• Patients who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.