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To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group Part I/Part II/Part III | Experimental | Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II: HRS-4642 combined with SHR-A1904Treatment group Part II: HRS-4642 combined with AG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4642 | Drug | Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II: HRS-4642 combined with SHR-A1904 Treatment group Part II: HRS-4642 combined with AG |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: (IB Period):DLTs | Within 28 days of the first dose | |
| Stage 1: (IB Period): adverse events (AEs) | Within 28 days of the first dos,About 1 year | |
| Phase II: (Phase II):investigator-assessed ORR | Assessed every 6 weeks,About 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: (IB Period):Investigator-assessed objective response rate (ORR) | Assessed every 6 weeks,About 1 year | |
| Phase II: (Phase II):DCR | Assessed every 6 weeks,About 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongxia Han | Contact | +0518-81220121 | hongxia.han@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| Phase II: (Phase II):DoR |
| Assessed every 6 weeks,About 1 year |
| Phase II: (Phase II):OS | Assessed every 6 weeks+ About 1 year |
| Phase II: (Phase II):PFS | Assessed every 6 weeks,About 1 year |
| Phase II: (Phase II):OS | Assessed approximately once every 1 month,About 1 year |
| Phase II: (Phase II):Incidence and severity of AEs | Assessed approximately once every 1 month,About 1 year |