A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: HLX208
level 1:600mg po Bid level 2:900mg po Bid
|
| Experimental: 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. |
Drug: HLX208
level 1:600mg po Bid level 2:900mg po Bid
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Cancer Hospita | Peking | Beijing | China | 100142 |
| 2 | Hunan cancer hospital | Changsha | China | ||
| 3 | West China Hospital of Sichuan University | Chendu | China | ||
| 4 | Fujian cancer hospital | Fujian | China | ||
| 5 | Shangxi Bethune Hospita | Taiyuan | China | ||
| 6 | union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China | ||
| 7 | Henan cancer hospital | Zhengzhou | China |
Sponsors and Collaborators
- Shanghai Henlius Biotech
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HLX208-MEL201