A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation

NCT ID: NCT05528406

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2025-06-01

Brief Summary

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX208

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

900mg bid po

Interventions

HLX208

900mg bid po

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age>=18Y
• Good Organ Function
• Expected survival time ≥ 3 months
• advanced solid tumors with BRAF V600 mutation that have been diagnosed
• Previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
• ECOG score 0-1;

Exclusion Criteria

• Previous treatment with BRAF inhibitors or MEK inhibitors
• Symptomatic brain or meningeal metastases (unless the patient has beenon > treatment for 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable)
• A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin
• Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva and vaginal melanoma are excluded.）
• Severe active infections requiring systemic anti-infective therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaohua Wu, PhD

Role: CONTACT

Wu.xh@fudan.edu.cn

021-34778299

Other Identifiers

HLX208-ST201

Identifier Type: -

Identifier Source: org_study_id