Back to resultsThe Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
Primary Purpose
Brain Tumor, Primary
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX208
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor, Primary
Eligibility Criteria
Inclusion Criteria:
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Refractory primary brain tumors with BRAF mutation that have been diagnosed
- Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
- ECOG score 0-1;
Exclusion Criteria:
- Previous treatment with BRAF inhibitors or MEK inhibitors
- A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
- Severe active infections requiring systemic anti-infective therapy
- Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Sites / Locations
- Cancer Hospital Affiliated to Shandong first medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLX208
Arm Description
Outcomes
Primary Outcome Measures
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO
Secondary Outcome Measures
PFS
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO
DOR
Duration of response
OS
Overall survival
Full Information
NCT ID
NCT05092802
First Posted
September 18, 2021
Last Updated
May 1, 2022
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT05092802
Brief Title
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
Official Title
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 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 refractory primary brain tumors with BRAF mutation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Primary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX208
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HLX208
Intervention Description
450mg bid po
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO
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 RANO
Time Frame
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year
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)，an average of about 1 year
Title
OS
Description
Overall survival
Time Frame
from the first dose to the time of death due to any cause，an average of about 2 year
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
Refractory primary brain tumors with BRAF mutation that have been diagnosed
Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
ECOG score 0-1;
Exclusion Criteria:
Previous treatment with BRAF inhibitors or MEK inhibitors
A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
Severe active infections requiring systemic anti-infective therapy
Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinming Yu
Phone
0531-67626819
Email
sdyujinming@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhehai Wang
Phone
0531-67626073
Email
ywb234@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinming Yu
Organizational Affiliation
Cancer Hospital Affiliated to Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Affiliated to Shandong first medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinming Yu
Phone
0531-67626819
Email
sdyujinming@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
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