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This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT and the recommended Phase 2 dose (RP2D) | Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41779980 | Derived | Liu T, Luo S, Yuan X, Liu D, Zhou Z, Wang X, Deng Y, Chen J, Liu M, Zhou H, Ren X, Qiu W, Cao Y, Cai S, Dong Y, Zhang Y, Wang W, Liang J, Xu P, Liu H, Zhao K, Fan Y, Dou N, Huang C, Li J. Trastuzumab Rezetecan in Human Epidermal Growth Factor Receptor 2-Expressing Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: A Multicenter, Open-Label, Phase I Trial. J Clin Oncol. 2026 May;44(13):1225-1237. doi: 10.1200/JCO-25-00716. Epub 2026 Mar 4. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |