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The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | SHR-A2102 and Adebrelimab |
|
| Treatment group 2 | Experimental | SHR-A2102 and Adebrelimab |
|
| Treatment group 3 | Active Comparator | Gemcitabine and cisplatin / carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 and Adebrelimab | Drug | SHR-A2102 and Adebrelimab injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS), assessed by BICR | up to 50 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case | Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case | |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun Yang | Contact | + 86 15001953916 | chun.yang.cy35@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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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine and cisplatin / carboplatin | Drug | Gemcitabine injection and cisplatin injection / carboplatin injection |
|
| up to 50 months |
| Objective response rate(ORR), assessed by BICR | up to 50 months |
| Disease control rate(DCR), assessed by BICR | up to 50 months |
| Duration of response(DoR), assessed by BICR | up to 50 months |
| PFS, assessed by investigator | up to 50 months |
| ORR, assessed by investigator | up to 50 months |
| DCR, assessed by investigator | up to 50 months |
| DoR, assessed by investigator | up to 50 months |
| Adverse event(AE) | up to 50 months |
| serious adverse event(SAE) | up to 50 months |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |