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The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1904 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1904 | Drug | SHR-A1904 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Maximum Tolerated Dose of SHR-A1904 | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | up to 1 year | |
| Time to maximum concentration (Tmax) | up to 1 year | |
| Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40670772 | Derived | Ruan DY, Wu HX, Luo SX, Huang WW, Liang XJ, Niu ZX, Dang Q, Li HL, Pan ZY, Lu HX, Zhang YQ, Li XY, Xiao XY, Cai SR, Dong YG, Zhang J, Li Z, Lan HT, Wang X, Zhou Y, Liu L, Liu HL, Xu PS, Suo AL, Jia RN, Li YQ, Peng XD, Wang SC, Yu AA, Xie J, Qiu MZ, Xu RH. The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial. Nat Med. 2025 Sep;31(9):3037-3046. doi: 10.1038/s41591-025-03781-w. Epub 2025 Jul 16. |
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SHR-A1904 monotherapy
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| up to 1 year |
| Anti-drug antibody (ADA) of SHR-A1904 | up to 1 year |
| Objective response rate (ORR) | up to 1 year |