This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Dose: 450 mg BID Regimen: twice daily (BID), continuous dosing Duration: until progression disease or unacceptable toxicity develops
Korea, Republic of, Gyeonggi-do
Seongnam-si, Gyeonggi-do, South Korea
Korea, Republic of, Gyeongsangbuk-do
Daegu, Gyeongsangbuk-do, South Korea
Korea, Republic of, Chungcheongbuk-do
Cheongju-si, North Chungcheong, South Korea
Korea, Republic of, Seoul
Seoul, South Korea
Objective response rate (Proportion of patients with reduction in tumor burden of a predefined amount)
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Safety and tolerability by assessing adverse events (AEs) based on CTCAE ver.4.03
Time frame: All AEs occurring up to 28 days after the last administration of study drug until the start of other anti-cancer treatment, whichever comes first, will be record.
Best overall response rate
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Disease control rate
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Progression-free survival
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Changes in molecular biomarkers
Time frame: Screening and 15 days after first dosing
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Korea, Republic of, Seoul
Seoul, South Korea
Korea, Republic of, Seoul
Seoul, South Korea
Korea, Republic of, Seoul
Seoul, South Korea