The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedStudy Start
First participant enrolled
December 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedMay 3, 2022
September 1, 2021
1.4 years
September 18, 2021
May 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO
from first dose to the last patient was followed up for 6 month
Secondary Outcomes (3)
PFS
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year
DOR
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
OS
from the first dose to the time of death due to any cause，an average of about 2 year
Study Arms (1)
HLX208
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital Affiliated to Shandong first medical University
Jinan, Shandong, 250117, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinming Yu
Shandong Cancer Hospital and Institute
Central Study Contacts
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
September 18, 2021
First Posted
October 26, 2021
Study Start
December 23, 2021
Primary Completion
May 30, 2023
Study Completion
May 30, 2024
Last Updated
May 3, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share