NCT05217303

HL-085 in NRAS-mutated Advanced Melanoma

A Single-arm, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of HL-085 in Advanced Melanoma Patients With NRAS Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Shanghai Kechow Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	HL-085	HL-085 capsule administered orally twice daily (BID) in a 21-day treatment cycle

Timeline

• Start date: 2020-11-02
• Primary completion: 2023-02-19
• Completion: 2023-02-20
• First posted: 2022-02-01
• Last updated: 2023-05-31

Locations

2 sites across 1 country: China