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This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients.
The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1A: SHR-A1811 and SHR-1701 | Experimental |
| |
| Arm 1B: SHR-A1811 and capecitabine | Experimental |
| |
| Arm 1C: SHR-A181, SHR-1701, and capecitabine | Experimental |
| |
| Arm 1D: SHR-A1811, SHR-1316, and capecitabine | Experimental |
| |
| Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Experimental |
| |
| Arm 1G: SHR-A1811, SHR-1316, and 5-FU | Experimental |
| |
| Arm 2A: SHR-A1811, SHR-1316, and capecitabine | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 and SHR-1701 | Drug | (Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs) | Safety will be assessed for approximately 24 months from informed consent | |
| Phase II: Objective Response Rate (ORR)[ | An average of approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Phase Ib) | An average of approximately 12 months | |
| DoR(Phase Ib) | An average of approximately 18 months | |
| PFS(Phase Ib) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Sun | Contact | +86 18036618554 | Shiwei.sun@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, FuDan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Arm 2B: SHR-1316 and SHR-A181 | Experimental |
|
| Arm 2C: SHR-A1811 and capecitabine | Experimental |
|
| Arm 2D: SHR-A1811, SHR-1316, and 5-FU | Experimental |
|
| Arm 2E: SHR-A1811and 5-FU | Experimental |
|
| Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Experimental |
|
| SHR-A1811 and capecitabine | Drug | (Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug:capecitabine, administered orally; |
|
| SHR-A181, SHR-1701, and capecitabine | Drug | (Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug:capecitabine, administered orally; |
|
| SHR-A1811, SHR-1316, and capecitabine | Drug | (Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug:capecitabine, administered orally; |
|
| SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Drug | (Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug:capecitabine, administered orally; Drug:oxaliplatin,administered as an IV infusion |
|
| SHR-A1811, SHR-1316, and 5-FU | Drug | (Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug:5-FU,administered as an IV infusion |
|
| SHR-A1811, SHR-1316, and capecitabine | Drug | (Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug:capecitabine, administered orally; |
|
| SHR-1316 and SHR-A1811 | Drug | (Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion |
|
| SHR-A1811 and capecitabine | Drug | (Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug:capecitabine, administered orally; |
|
| SHR-A1811, SHR-1316, and 5-FU | Drug | (Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug:5-FU,administered as an IV infusion |
|
| SHR-A1811and 5-FU | Drug | (Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug:5-FU,administered as an IV infusion |
|
| SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Drug | (Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug:capecitabine, administered orally; Drug:oxaliplatin,administered as an IV infusion |
|
| An average of approximately 18 months |
| OS(Phase Ib) | An average of approximately 30 months |
| DoR(Phase II) | An average of approximately 18 months |
| PFS(Phase II) | An average of approximately 18 months |
| OS(Phase II) | An average of approximately 30 months |
| Occurrence of adverse events (AEs), and serious adverse events (SAEs) (Phase II) | Safety will be assessed for approximately 24 months from informed consent] |
| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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