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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech

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