A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation

May 1, 2022 updated by: Shanghai Henlius Biotech

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Changsha, China
      • Chendu, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Fujian, China
      • Taiyuan, China
        • Not yet recruiting
        • Shangxi Bethune Hospita
        • Contact:
          • Huijing Feng
      • Wuhan, China
        • Not yet recruiting
        • Union Hospital Tongji Medical College， Huazhong University of Science and Technology
        • Contact:
      • Zhengzhou, China
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
    • Beijing
      • Peking, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospita
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age>=18Y
  • Good Organ Function
  • Expected survival time ≥ 3 months
  • advanced melanoma with BRAF V600 mutation that have been diagnosed
  • ECOG score 0-1;

Exclusion Criteria:

  • Previous treatment with BRAF inhibitors or MEK inhibitors
  • Symptomatic brain or meningeal metastases (unless the patient has beenon > treatment for 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).
  • Severe active infections requiring systemic anti-infective therapy
  • A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose-escalation stage
Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
Drug: HLX208
level 1:600mg po Bid level 2:900mg po Bid
EXPERIMENTAL: Dose-expansion stage
Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208.
Drug: HLX208
level 1:600mg po Bid level 2:900mg po Bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: from first dose to the last patient was followed up for 6 month
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
from first dose to the last patient was followed up for 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years
DOR
Time Frame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years
Duration of response
from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years
OS
Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years
Overall survival
from the first dose to the time of death due to any cause，assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2022

Primary Completion (ANTICIPATED)

August 30, 2023

Study Completion (ANTICIPATED)

August 30, 2024

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (ACTUAL)

November 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 1, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX208-MEL201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe