Brain Tumor, Primary
Conditions
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
Interventions
DRUGHLX208
450mg bid po
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 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 RANO |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year | Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO |
| 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 | Duration of response |
| OS | from the first dose to the time of death due to any cause，an average of about 2 year | Overall survival |
Countries
China
Contacts
Primary ContactJinming Yu
Backup ContactZhehai Wang
Outcome results
None listed