The aim of this study is to evaluate the efficacy and safety of vediximab monotherapy or in combination with enrolizumab for second-line treatment of CDK12 alterations mCRPC that has failed standard therapy. The research results are expected to provide new insights and breakthroughs for the treatment of advanced prostate cancer.
Participants must be able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign a written informed consent form;
Patients aged ≥ 18 years old;
Pathological examination confirms non resectable or metastatic HER2 positive castration resistant prostate cancer (mCRPC): HER2 positive is defined as IHC 3+or IHC 2+or FISH+;
Carrying CDK12 mutation combined with ERBB amplification (NGS or FISH) or HER2 IHC (1+, 2+, 3+);
Individuals with a known history of allergies to the components of this medication regimen;
Have other malignant tumors within the past 5 years prior to signing the informed consent form (excluding non melanoma skin cancer or other tumors that have been effectively treated, and malignant tumors that are considered cured);
Existence of brain metastases and/or cancerous meningitis;
Previously received allogeneic stem cell or parenchymal organ transplantation;
Single group
RC48
DrugDuring the patient treatment phase, the subjects received intravenous infusion of Disitamab Vedotin(RC48) (2.0 mg/kg) every 2 weeks until disease progression or death occurred.
Envafolimab
DrugDuring the treatment phase of the patient, the subjects received subcutaneous injections of Envafolimab (400 mg) every 3 weeks until the patient experienced disease progression or death.
Prostate Specific Antigen (PSA) ≥50% Response Rate (PSA50)
Will assess PSA decline of ≥50% from baseline (PSA50), using the Prostate Cancer Working Group 3 (PCWG3) criteria.
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1).
Progression Free Survival(PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1
Overall Survival(OS)
Time from start of treatment to death due to any cause.
Percentage of Participants With Adverse Events (AEs)
Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0
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