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

Inclusion Criteria:

• Voluntary agreement to provide written informed consent.
• Male or female, Age ≥ 18 years.
• Predicted survival ≥ 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• All female subjects will be considered to be of child-bearing potential unlessparticipants are postmenopausal, or have been sterilized surgically.Female subjects ofchild-bearing potential must agree to use two forms of highly effective contraception.Male subjects and their female partner who are of child-bearing potential must agreeto use two forms of highly effective contraception.
• Willing to adhere to the study visit schedule and the prohibitions and restrictionsspecified in this protocol.
• Adequate organ function.
• All subjects must be histologically confirmed, non-resectable stage III or metastaticmelanoma, except for patients with uveal or ocular melanoma.
• The subject has experienced disease progression or intolerance after receivingstandard treatment in the past; Patients with disease progression within 6 monthsafter receiving neoadjuvant or adjuvant chemotherapy regimens can be included in theclinical study.
• The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable;the subject can provide the Specimen of primary or metastatic tumor for HER2review/judgment.
• According to the RECIST 1.1 standard, there is at least one measurable lesion.

Exclusion Criteria:

• Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAEConjugate For Injection.
• History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior totrial treatment.
• Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
• Treated with systemic treatment (e.g. immunomodulators, corticosteroids orimmunosuppressants) for the autoimmune disease within 2 years prior to the studytreatment.
• 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 (withexception 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 abnormalitythat might confound the results of the trial, interfere with the subject'sparticipation for the full duration of the trial, or is not in the best interest ofthe subject to participate, in the opinion of the treating investigator.
• History of other malignancy within the previous 5 years, except for appropriatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers witha similar curative outcome as those mentioned above.
• Assessed by the investigator to be unable or unwilling to comply with the requirementsof the protocol.