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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2102 group | Experimental |
| |
| Investigator-selected therapy group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 for Injection | Drug | SHR-A2102 for Injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Up to approximately 1.5 years. | |
| Overall Survival (OS) | Up to approximately 1.5 years and 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 1.5 years and 2 years. | |
| Disease Control Rate (DCR) | Up to approximately 1.5 years and 2 years. | |
| Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Zhang, M.M | Contact | +86-18456513908 | chi.zhang@hengrui.com | |
| Zhaoxiang Wang, M.M | Contact | +86-19181783204 | zhaoxiang.wang.zw170@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Docetaxel Injection |
| Drug |
Docetaxel Injection. |
|
| Paclitaxel Injection | Drug | Paclitaxel Injection. |
|
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine Hydrochloride for Injection. |
|
| Pemetrexed Disodium for Injection | Drug | Pemetrexed Disodium for Injection. |
|
| Up to approximately 1.5 years and 2 years. |
| Serum concentrations of SHR-A2102 | Up to approximately 2 years. |
| Serum concentrations of SHR-A2102 toxin | Up to approximately 2 years. |
| Anti-SHR-A2102 antibody (ADA) | Up to approximately 2 years. |
| Anti-SHR-A2102 neutralizing antibody (NAb) | Up to approximately 2 years. |
| Incidence and severity of adverse event (AE) | Up to approximately 2 years. |
| Incidence and severity of serious adverse event (SAE) | Up to approximately 2 years. |
| ID | Term |
|---|---|
| D007267 | Injections |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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