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

Phase 2

• Conditions: Brain Tumor, Primary
• Interventions: Drug: HLX208

• Registration Number: NCT05092802
• Lead Sponsor: Shanghai Henlius Biotech

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-26
• Study Start: 2021-12-23
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-03
• Primary Completion: 2023-05-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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;

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLX208	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 RANO

Secondary Outcome Measures

Name	Time	Method
OS	from the first dose to the time of death due to any cause，an average of about 2 year	Overall survival
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)，an average of about 1 year	Duration of response
PFS	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year	Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO

Trial Locations

Locations (1)

Cancer Hospital Affiliated to Shandong first medical University; 🇨🇳 Jinan, Shandong, China