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

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

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor, Primary
• Intervention / Treatment: Drug: HLX208

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinming Yu; Phone Number: 0531-67626819; Email: sdyujinming@126.com
• Study Contact Backup: Name: Zhehai Wang; Phone Number: 0531-67626073; Email: ywb234@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Cancer Hospital Affiliated to Shandong First Medical University
      • Contact: Jinming Yu; Phone Number: 0531-67626819; Email: sdyujinming@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX208	Drug: HLX208; 450mg bid po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
OS	Overall survival	from the first dose to the time of death due to any cause，an average of about 2 year

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech
• Investigators: Principal Investigator: Jinming Yu, Cancer Hospital Affiliated to Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: HLX208-BT201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No