A Phase 2 interventional study of HLX208 in Advanced Melanoma, sponsored by Shanghai Henlius Biotech. Status unknown at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Shanghai Henlius Biotech · Phase 2, Interventional, and Treatment
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 30 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Shanghai Henlius Biotech is the lead sponsor of 127 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
Drug: HLX208
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
level 1:600mg po Bid level 2:900mg po Bid
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
Time frame: from first dose to the last patient was followed up for 6 month
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Shanghai Henlius Biotech