HL-085 in NRAS-mutated Advanced Melanoma

Sponsor

Shanghai Kechow Pharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05217303

Collaborator

(none)

100

Enrollment

Locations

Arm

24.6

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: HL-085	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Anticipated Primary Completion Date :

Apr 20, 2022

Anticipated Study Completion Date :

Nov 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HL-085 12 mg BID HL-085	Drug: HL-085 HL-085 capsule administered orally twice daily (BID) in a 21-day treatment cycle

Arm

Intervention/Treatment

Experimental: HL-085

12 mg BID HL-085

Drug: HL-085

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

Outcome Measures

Primary Outcome Measures

objective response rate (ORR) [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

Secondary Outcome Measures

progression-free survival (PFS) [through study completion, an average of 1 year]
To evaluate the progression-free survival (PFS), disease control rate (DCR), duration of remission (DOR) of patients with advanced melanoma harboring NRAS mutation after HL-085 treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 0-1.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China	100142
2	Beijing Oncology Hospital	Beijing	Beijing	China

Sponsors and Collaborators

Shanghai Kechow Pharma, Inc.

Investigators

Study Director: Hongqi Tian, Ph.D, Shanghai Kechow Pharma, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Kechow Pharma, Inc.

ClinicalTrials.gov Identifier:

NCT05217303

Other Study ID Numbers:

HL-085-101-II

First Posted:

Feb 1, 2022

Last Update Posted:

Feb 1, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shanghai Kechow Pharma, Inc.

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Feb 1, 2022