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

Shanghai Kechow Pharma, Inc.2 sites in 1 country100 target enrollmentNovember 2, 2020

ConditionsMelanoma

InterventionsHL-085

DrugsHL-085

Overview

Phase: Phase 2
Intervention: HL-085
Conditions: Melanoma
Sponsor: Shanghai Kechow Pharma, Inc.
Enrollment: 100
Locations: 2
Primary Endpoint: objective response rate (ORR)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2, 2020

End Date

February 20, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Kechow Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18 Years or older (male or female).
•Patients have histologically or cytologically confirmed Unresectable stage III or IV melanoma;
•Able to provide the genetic test report with documented NRAS mutation at baseline.
•At least one target lesion as per RECIST v1.1 criteria.
•Previous chemotherapy, immunotherapy, or radiotherapy must have been completed at least 4 weeks prior to study drug administration, and all related toxic reactions (with the exception of alopecia) must have been resolved (to Grade ≤1 or baseline) prior to study drug administration.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•Life expectancy \> 3 months.
•No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 14 days prior to study drug administration.

Exclusion Criteria

•Patients with active central nervous system (CNS) lesions (i.e., radiological evidence of instability, symptomatic lesions) should be excluded. Note: Patients receiving stereotactic brain radiotherapy or surgery who have shown no brain disease progression over a period of 3 months or longer are eligible for inclusion.
•Patients had received any other study treatment within the past 4 weeks prior to study drug administration.
•Inability to swallow the capsule, refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or any small intestinal resection that would preclude adequate absorption of the study drug.
•ECG QTcB ≥ 480 msec (adjusted by Bazetts formula) during screening, or a history of congenital long QT syndrome.
•Bleeding symptoms of Grade 3 as defined by the National Cancer Institute General Terminology Standard for Adverse Events (NCI CTCAE V5.0) within the past 4 weeks prior to study initiation.
•One of the following situations occurs within the past 6 months prior to administration of study drug: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, serious arrhythmia, uncontrolled hypertension, cerebrovascular accident, or transient ischemic attack, or symptomatic pulmonary embolism.
•Current use of other anti-cancer drugs (hormone therapy was acceptable).
•Uncontrolled concomitant diseases or infectious diseases.
•Patients have retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) or other retinal diseases previously or currently.

Arms & Interventions

HL-085

12 mg BID HL-085

Intervention: HL-085

Outcomes

Primary Outcomes

objective response rate (ORR)

Time Frame: through study completion, an average of 1 year

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