A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma

Inclusion criteria

• Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic malignant melanoma (except for uveal melanoma) who have failed in the prior systemic therapy .
• Adequate organ and hematologic function.
• At least 1 extracranial measurable lesion.
• An ECOG activity status score of 0-1.
• A life expectancy of ≥ 3 months.
• Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
• Good compliance and willingness to follow up.

Exclusion criteria

• Prior to first dose, received systemic antitumor therapy , scheduled major surgical procedure within 4 weeks , received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
• A history of active autoimmune disease within the past 2 years.
• A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities or LVEF<50%. A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
• A severe acute or chronic infection when enrollment.
• Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• Unresolved > grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
• Clinically active CNS metastases or meningeal metastases.
• A history of other type of malignancies.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• Poor compliance.
• A history of alcohol/drugs abuse.
• Current pregnancy or breastfeeding.
• Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.