Solid Tumor
Conditions
Brief summary
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation
Interventions
DRUGHLX208
900mg 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 * advanced solid tumors with BRAF V600 mutation that have been diagnosed * Previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage. * 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 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable) * A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin * Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva and vaginal melanoma are excluded.） * Severe active infections requiring systemic anti-infective therapy
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 e RECIST Version 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| OS | [Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years] | Overall survival |
Contacts
Primary ContactXiaohua Wu, PhD
Outcome results
None listed