A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor 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 (BRAF V600E Inhibitor) in Advanced Solid Tumor 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 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation

Conditions
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Solid Tumor

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 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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX208<br> | Drug: HLX208<br>* 900mg bid po<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 | [Time Frame: 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 | [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] | 
| OS | Overall survival | [Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years] |