A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation

Study Overview
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Brief Summary
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An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation

Official Title
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An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation

Conditions
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Advanced Melanoma

Intervention / Treatment
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* Drug: HLX208


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose-escalation stage<br>Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding. | Drug: HLX208<br>* level 1:600mg po Bid level 2:900mg po Bid<br>|
| Experimental: Dose-expansion stage<br>Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208. | Drug: HLX208<br>* level 1:600mg po Bid level 2:900mg po Bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1) | from first dose to the last patient was followed up for 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1 | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years | 
| DOR | Duration of response | 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 | 
| OS | Overall survival | from the first dose to the time of death due to any cause，assessed up to 2 years |