A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)

Exclusion Criteria

• •Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
• •History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
• •Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
• •Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
• •History of major surgery within 4 weeks of planned start of trial treatment.
• •Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
• •Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
• •Pregnancy or lactation.
• •Currently known active infection with HIV or tuberculosis.
• •Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
• •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.