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

Henlius Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Advanced Melanoma

Treatments: Drug: HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT05114603

HLX208-MEL201

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dose-escalation stage

Experimental group

Description:

Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.

Treatment:

Drug: HLX208

Dose-expansion stage

Experimental group

Description:

Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208.

Treatment:

Drug: HLX208