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

Henlius Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Brain Tumor, Primary

Treatments: Drug: HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT05092802

HLX208-BT201

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

HLX208

Experimental group

Treatment:

Drug: HLX208