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This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI363 | Drug | IBI363 Q3W Oxaliplatin 130 mg/m2,IV,Q3W, Capecitabine ,1000mg/ m2,PO,Bid,d1-14,Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The efficacy of solid tumors was evaluated according to RECIST v1.1 | Through out the study (up to 2 years) |
| Disease control rate (DCR) | The efficacy of solid tumors was evaluated according to RECIST v1.1 | Through out the study (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS); | The efficacy of solid tumors was evaluated according to RECIST v1.1 | Up to 2 years |
| Overall Survival, OS) | The efficacy of solid tumors was evaluated according to RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanxi Pu | Contact | 18523197816 | yanxi.pu@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Up to 2 years |
| Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE) | Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0. | Up to 90 days after the last administration |