This was an open-label, single-arm, multi-center phase II clinical study, aimed at investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma patients with NRAS mutation.
This was an open-label, single-arm, multi-center phase II clinical study, aimed at investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma patients with NRAS mutation. The primary objective was to evaluate the objective response rate (ORR) of oral HL-085 capsule in patients with advanced melanoma harboring NRAS mutation. The secondary objectives were to evaluate the progression-free survival (PFS), disease control rate (DCR), duration of remission (DOR), 1-year survival rate, overall survival (OS) and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
HL-085 capsule administered orally twice daily (BID) in a 21-day treatment cycle
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Oncology Hospital
Beijing, Beijing Municipality, China
objective response rate (ORR)
To evaluate the objective response rate (ORR) of patients with advanced melanoma harboring NRAS mutation. ORR by RECIST v1.1 following treatment with HL-085
Time frame: through study completion, an average of 1 year
progression-free survival (PFS)
To evaluate the progression-free survival (PFS), disease control rate (DCR), duration of remission (DOR) of patients with advanced melanoma harboring NRAS mutation after HL-085 treatment.
Time frame: through study completion, an average of 1 year
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