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This is a multicenter, open-label, single-arm, phase II cilinical trial designed to evaluate the efficacy and safety of the KRAS G12C selective inhibitor HRS-7058 in patients with KRAS G12C-mutated advanced pancreatic cancer who had failed 1-2 lines of previous systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-7058 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7058 | Drug | HRS-7058 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR as assessed by IRC | IRC evaluation | About 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed ORR | Assessments BY INVESTIGATORS | About 2 years |
| IRC and investigator-assessed DoR | IRC and investigator assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Qin | Contact | +0518-81220121 | meng.qin.mq8@hengrui.com | |
| Keke Yan | Contact | +0518-81220121 | keke.yan@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210003 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| About 2 years |
| IRC and investigator-assessed DCR | IRC and investigator assessments | About 2 years |
| IRC and investigator-assessed PFS | IRC and investigator assessments | About 2 years |
| OS | Assessments BY INVESTIGATORS | About 4 years |
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |