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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-23

Study Completion Date

2024-05-30

Brief Summary

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

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Detailed Description

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Conditions

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Brain Tumor, Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HLX208

Group Type EXPERIMENTAL

HLX208

Intervention Type DRUG

450mg bid po

Interventions

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HLX208

450mg bid po

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No