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

Advanced Melanoma Clinical Trial

Official title:

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114603
• Other study ID #: HLX208-MEL201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 21, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2021
• Source: Shanghai Henlius Biotech
• Contact: Jun Guo
• Phone: 88196391
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Intervention

Drug:
• HLX208
level 1:600mg po Bid level 2:900mg po Bid

Locations

Country	Name	City	State
China	Hunan cancer hospital	Changsha
China	West China Hospital of Sichuan University	Chendu
China	Fujian cancer hospital	Fujian
China	Peking University Cancer Hospita	Peking	Beijing
China	Shangxi Bethune Hospita	Taiyuan
China	union Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Henan cancer hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS	Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 years
Secondary	DOR	Duration of response	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
Secondary	OS	Overall survival	from the first dose to the time of death due to any cause,assessed up to 2 years