A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma
Trial Parameters
Brief Summary
This study will evaluate the efficacy and safety of RC48-ADC combined with AK104 in HER2-expression locally advanced or metastatic urothelial carcinoma.
Eligibility Criteria
Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Male or female, Age ≥ 18 years. * Predicted survival ≥ 6 month. * Histologically and/or cytologically confirmed locally advanced or metastatic urothelial carcinoma (including urothelial carcinoma originating in the renal pelvis, ureter, bladder, or urethra). * Pior not received systemic therapy, and can not tolerant cisplatin or refuse chemotherapy. * HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Have at least one evaluable lesion (RECIST 1.1 criteria) * Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment. * Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. * Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. Excl