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

Phase 2

• Conditions: Advanced Melanoma
• Interventions: Drug: HLX208

• Registration Number: NCT05114603
• Lead Sponsor: Shanghai Henlius Biotech

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Study Start: 2022-03-21
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-03
• Primary Completion: 2023-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose-escalation stage	HLX208	Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
Dose-expansion stage	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (7)

Peking University Cancer Hospita; 🇨🇳 Peking, Beijing, China

West China Hospital of Sichuan University; 🇨🇳 Chendu, China

Shangxi Bethune Hospita; 🇨🇳 Taiyuan, China

Hunan cancer hospital; 🇨🇳 Changsha, China

Henan cancer hospital; 🇨🇳 Zhengzhou, China

union Hospital Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Fujian cancer hospital; 🇨🇳 Fujian, China