The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment

Brain Tumor, Primary Clinical Trial

Official title:

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092802
• Other study ID #: HLX208-BT201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 23, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: September 2021
• Source: Shanghai Henlius Biotech
• Contact: Jinming Yu
• Phone: 0531-67626819
• Email: sdyujinming[@]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 refractory primary brain tumors with BRAF mutation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2024
• Est. primary completion date: May 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
• Refractory primary brain tumors with BRAF mutation that have been diagnosed
• Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
• ECOG score 0-1;

Exclusion Criteria:

• Previous treatment with BRAF inhibitors or MEK inhibitors
• A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
• Severe active infections requiring systemic anti-infective therapy
• Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Primary

Intervention

Drug:
• HLX208
450mg bid po

Locations

Country	Name	City	State
China	Cancer Hospital Affiliated to Shandong first medical University	Jinan	Shandong

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 RANO	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 RANO	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),an average of about 1 year
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),an average of about 1 year
Secondary	OS	Overall survival	from the first dose to the time of death due to any cause,an average of about 2 year