Back to resultsA Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
Primary Purpose
Advanced Melanoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX208
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Melanoma
Eligibility Criteria
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.
Sites / Locations
- Peking University Cancer HospitaRecruiting
- Hunan cancer hospitalRecruiting
- West China Hospital of Sichuan University
- Fujian cancer hospital
- Shangxi Bethune Hospita
- union Hospital Tongji Medical College, Huazhong University of Science and Technology
- Henan cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose-escalation stage
Dose-expansion stage
Arm Description
Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
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.
Outcomes
Primary Outcome Measures
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
Secondary Outcome Measures
PFS
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1
DOR
Duration of response
OS
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05114603
Brief Title
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
Official Title
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose-escalation stage
Arm Type
Experimental
Arm Description
Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
Arm Title
Dose-expansion stage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HLX208
Intervention Description
level 1:600mg po Bid level 2:900mg po Bid
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
Time Frame
from first dose to the last patient was followed up for 6 month
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1
Time Frame
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years
Title
DOR
Description
Duration of response
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
Title
OS
Description
Overall survival
Time Frame
from the first dose to the time of death due to any cause，assessed up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo
Phone
88196391
Email
guoj307@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Si
Phone
88196391
Ext
88196391
Email
silu15_silu@126.com
Facility Information:
Facility Name
Peking University Cancer Hospita
City
Peking
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Si, MD PhD
Email
silu15_silu@126.com
Facility Name
Hunan cancer hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingxiang Pu
Email
puxingxiang@hnca.org.cn
Facility Name
West China Hospital of Sichuan University
City
Chendu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyan Liu
Email
liujiyan1972@163.com
Facility Name
Fujian cancer hospital
City
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chen
Email
13859089836@136.com
Facility Name
Shangxi Bethune Hospita
City
Taiyuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijing feng
Facility Name
union Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Chen
Email
bswhunion@163.com
Facility Name
Henan cancer hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weitao Yao
Email
ywtwhm@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
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