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

NCT05263453 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-05-31

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shanghai Kechow Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Hongqi Tian, Ph.D · Shanghai Kechow Pharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263453 on ClinicalTrials.gov