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;