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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05217303
Study type Interventional
Source Shanghai Kechow Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 2, 2020
Completion date February 20, 2023

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