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

UNKNOWNPHASE2

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

NCT05092802•Shanghai Henlius Biotech

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Cancer Hospital Affiliated to Shandong first medical University

Jinan, Shandong, China

Key Dates

Start Date

December 23, 2021

Primary Completion Date

May 30, 2023

Completion Date

May 30, 2024

Last Updated

May 3, 2022

Enrollment

ESTIMATED participants

Conditions

Brain Tumor, Primary

Interventions

HLX208

DRUG

Contacts

Jinming Yu

CONTACT

0531-67626819 sdyujinming@126.com

Zhehai Wang

CONTACT

0531-67626073 ywb234@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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