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The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-3802 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-3802 | Drug | HRS-3802 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and the severity of adverse events | Every 4 weeks after treatment initiation (through study completion,an average 5 mouths) | |
| Dose-limiting toxicity (DLT) | During the first 28-day cycle of HRS-3802 treatment | |
| Maximum tolerated dose (MTD) | 3 weeks after treatment initiation | |
| Recommended Phase II Dose (RP2D) | 3 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) - RECIST 1.1 | ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1. | Up to approximately 6 months |
| Duration of Response (DoR) per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu | Contact | 0518-82342973 | xiaoyu.zhu@hengrui.com | |
| Yueling Wang | Contact | 021-60453139 | yueling.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GenesisCare North Shore (Oncology) | Active, not recruiting | Saint Leonards | New South Wales | 2065 | Australia | |
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| Up to approximately 2 years |
| Progression-free survival (PFS) per RECIST 1.1 | Up to approximately 2 years |
| Macquarie University Hospital |
| Active, not recruiting |
| Sydney |
| New South Wales |
| 2109 |
| Australia |
| John Flynn Private Hospital | Active, not recruiting | Tugun | Queensland | 4224 | Australia |
| GenesisCare St Andrews | Active, not recruiting | Adelaide | South Australia | 5000 | Australia |
| Peninsula and South Eastern Haematology & Oncology Group | Active, not recruiting | Frankston | Victoria | 3199 | Australia |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
|