Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)

Inclusion Criteria: 1) Prostate cancer confirmed by histology; 2) ≥ 18 years old; 3) The presence of metastatic lesions confirmed by bone scan and/or CT/MRI and/or PET-CT; 4) ECOG score 0-2; 5) Continuously maintain ADT treatment and maintain testosterone levels ≤ 50ng/dL; The progression of prostate cancer recorded within 6 months prior to screening; 6) Having received at least one NHT in the past before progressing; 7) HER2 IHC 1+, 2+, or 3+; 8) Inability to or refusal docetaxel chemotherapy; 9) Voluntarily join the study; 10) Expected survival time ≥ 6 months; 11) Normal function of main organs; Exclusion Criteria: 1)Have a history of malignant tumors other than prostate cancer; 2)Previously received allogeneic stem cell or parenchymal organ transplantation; 3) Previously or currently suffering from congenital or acquired immunodeficiency diseases; 4) The patient have a history of allergy to RC48 or paclitaxel, or a history of Hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to excipients of the study drug; 5) Other significant clinical and laboratory abnormalities that affect safety evaluation; 6) Those who are unwilling or unable to take effective contraceptive measures; 7) Subjects with active brain metastasis;