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This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-8364 Group | Experimental | HRS-8364 in different doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8364 Tablet | Drug | HRS-8364 tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Dose-Limiting Toxicity (DLT) | Post-dose at Day 1 to Day 21. | |
| The Maximum Tolerated Dose (MTD) | Post-dose at Day 1 to the end of treatment visit, about 1 year. | |
| Recommended dosage for Phase II (RP2D) | Post-dose at Day 1 to the end of treatment visit, about 1 year. | |
| Incidence and severity of adverse events (AEs) | From signing the informed consent form to safety follow-up completed, about 1 year. | |
| Objective Response Rate (ORR) | From the first administration to the end of treatment visit, about 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of HRS-8364 (Cmax) | Day 1 pre-dose to the end of treatment visit, about 1 year. | |
| Time to maximum plasma concentration (Tmax) | Day 1 pre-dose to the end of treatment visit, about 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Wen | Contact | +86-021-61053363 | cong.wen@hengrui.com | |
| Weixia Li | Contact | +86-021-61053363 | weixia.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun-Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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An open label ,multicenter, phase I/II clinical study.
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| Area under the concentration versus time curve of HRS-8364 from time zero to time t (AUC0-t). | Day 1 pre-dose to the end of treatment visit, about 1 year. |
| Bioaccumulation of HRS-8364 in postprandial relative fasting state. | Cycle 0 Day1 pre-dose to Cycle 1 Day 3, about 6 days. |
| Duration of relief (DOR). | From the first administration to the end of treatment visit, about 1 year. |
| Disease Control Rate (DCR). | From the first administration to the end of treatment visit, about 1 year. |
| Progression-free survival (PFS). | From the first administration to the end of treatment visit, about 1 year. |
| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | 110042 | China |
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