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This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD). |
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| Dose Expansion | Experimental | Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-460372 | Drug | Subjects will receive BPI-460372 until disease progression |
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| Measure | Description | Time Frame |
|---|---|---|
| The adverse events (AEs) | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs). | Through the Phase I, approximately 24 months |
| The dose-limiting toxicity(DLT) | The dose-limiting toxicity | Through the Phase I, approximately 24 months |
| Determine the Maximum Tolerated Dose (MTD) | The MTD will be based on DLT. | Through the Phase I, approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics of BPI-460372 | Based on blood plasma concentration | Time Frame: Through the Phase I, approximately 24 months |
| Evaluate the effectiveness of BPI-460372 | Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengzhao Wang, Ph.D | Contact | 010-69155039 | mengzhaowang@sina.com | |
| Xiaohong Han, Ph.D | Contact | 010-69156114 | hanxiaohong@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Time Frame: Through the Phase I, approximately 24 months |
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Affiliated Hospital of Hebei University | Recruiting | Baoding | Hebei | 050031 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Tongji Hospital Tongji Medical College of HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410031 | China |
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| China-Japan Union Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130033 | China |
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| Central Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | 250013 | China |
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| Shandong Cancer Hospital | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Taizhou Hospital of Zhejiang Province | Not yet recruiting | Taizhou | Zhejiang | 317000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Zhengzhou | 450052 | China |
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