NCT05263453

HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation

A Single-arm, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of the Combination of HL-085 and Vemurafenib in Advanced Melanoma Patients With BRAF V600E/K Mutation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Shanghai Kechow Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to Evaluate the Efficacy and Safety of the combination of HL-085 and Vemurafenib in Advanced Melanoma Patients with BRAF V600E/K Mutation. This study includes IIa and IIb phase. Phase IIa will determine the dose regiment for Phase IIb. Phase IIb part will evaluate the efficacy and safety with this combination regiment.

Detailed description

This is a single-arm, multi-center Phase II trial to evaluate the efficacy and safety of the combination of HL-085 and Vemurafenib in advanced melanoma patients with BRAF V600E/K mutation. There are two phase of this study ( IIa and IIb). Phase IIa will be evaluating the safety and efficacy of the combination regiment (HL-08512mg +Vemurafenib 720mg, and/or some lower dose regiment, such as 9mg+720mg) in 20-30 patients, and final determine the recommended dose regiment for Phase IIb. In Phase IIb will enrolled 74 patients , the primary endpoint is ORR, and the secondary endpoint are PFS. The safety profile of this combined HL-085/Vemurafenib regimen will be monitored during both phases. The treatment period consists of 21-day cycles until progression or unacceptable toxicity occurs.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	HL-085	HL-085 capsule 12mg administered orally twice daily in a 21-day treatment cycle
DRUG	Vemurafenib	Vemurafenib tablet 720mg administered orally twice daily in a 21-day treatment cycle

Timeline

• Start date: 2021-09-06
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2022-03-02
• Last updated: 2023-05-31

Locations

1 site across 1 country: China