A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
NCT ID: NCT05114603
Last Updated: 2022-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2022-03-21
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose-escalation stage
Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
HLX208
level 1:600mg po Bid level 2:900mg po Bid
Dose-expansion stage
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.
HLX208
level 1:600mg po Bid level 2:900mg po Bid
Interventions
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HLX208
level 1:600mg po Bid level 2:900mg po Bid
Eligibility Criteria
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Inclusion Criteria
* Good Organ Function
* Expected survival time ≥ 3 months
* advanced melanoma with BRAF V600 mutation that have been diagnosed
* ECOG score 0-1;
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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Peking University Cancer Hospita
Beijing, Beijing Municipality, China
Hunan cancer hospital
Changsha, , China
West China Hospital of Sichuan University
Chendu, , China
Fujian cancer hospital
Fujian, , China
Shangxi Bethune Hospita
Taiyuan, , China
union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Henan cancer hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Huijing feng
Role: primary
Other Identifiers
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HLX208-MEL201
Identifier Type: -
Identifier Source: org_study_id
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