This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study.
This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study. Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death. During the treatment, participants will evaluate every 4 weeks, including PSA testing every 4 weeks and tumor evaluation according to PCWG3 standards every 8 weeks. If the patient develops disease progression, the treatment will be discontinued and survival follow-up will be conducted every 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death.
PSA response rate
The proportion of subjects receiving at least one cycle of treatment with the study drug who had at least a 50% reduction in PSA from baseline and maintained it for more than 21 days (PSA50).
Time frame: 24 months
ORR,Objective Response Rate
The proportion of patients who achieved patial response and complete reponse.
Time frame: 24 months
Overall survival (OS)
median OS or OS rate
Time frame: From the first dose to death from any cause,up to two years.
Progression free survival
median PFS or PFS rate
Time frame: From the first dose to the first documentation of disease progression or death, up to two years.
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