NCT05217303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

January 7, 2022

Last Update Submit

May 29, 2023

Conditions

Melanoma

Keywords

HL-085MEK inhibitorNRAS mutationadvanced melanoma

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR)

    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

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • progression-free survival (PFS)

    through study completion, an average of 1 year

Study Arms (1)

HL-085

EXPERIMENTAL

12 mg BID HL-085

Drug: HL-085

Interventions

HL-085DRUG

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

HL-085

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Oncology Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hongqi Tian, Ph.D

    Shanghai Kechow Pharma, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 1, 2022

Study Start

November 2, 2020

Primary Completion

February 19, 2023

Study Completion

February 20, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)