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

• Status: Recruiting
• Trial end date: 2024-05-30
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma 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 melanoma with BRAF V600 mutation that have been diagnosed

• 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 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).

• Severe active infections requiring systemic anti-infective therapy

• A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.