Advanced Melanoma
Conditions
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
Interventions
DRUGHLX208
level 1:600mg po Bid level 2:900mg po Bid
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
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 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.
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 | 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 | 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 | from the first dose to the time of death due to any cause，assessed up to 2 years | Overall survival |
Countries
China
Contacts
Primary ContactJun Guo
Backup ContactLu Si
Outcome results
None listed