To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
402
SHR-A2102 for Injection.
Docetaxel Injection.
Paclitaxel Injection.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-free Survival (PFS)
Time frame: Up to approximately 1.5 years.
Overall Survival (OS)
Time frame: Up to approximately 1.5 years and 2 years.
Objective Response Rate (ORR)
Time frame: Up to approximately 1.5 years and 2 years.
Disease Control Rate (DCR)
Time frame: Up to approximately 1.5 years and 2 years.
Duration of Response (DoR)
Time frame: Up to approximately 1.5 years and 2 years.
Serum concentrations of SHR-A2102
Time frame: Up to approximately 2 years.
Serum concentrations of SHR-A2102 toxin
Time frame: Up to approximately 2 years.
Anti-SHR-A2102 antibody (ADA)
Time frame: Up to approximately 2 years.
Anti-SHR-A2102 neutralizing antibody (NAb)
Time frame: Up to approximately 2 years.
Incidence and severity of adverse event (AE)
Time frame: Up to approximately 2 years.
Incidence and severity of serious adverse event (SAE)
Time frame: Up to approximately 2 years.
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Gemcitabine Hydrochloride for Injection.
Pemetrexed Disodium for Injection.