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This study is designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1167 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1167 | Drug | Participants will receive HRS-1167. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) of HRS-1167 | up to 24 days | |
| Maximum tolerated dose (MTD) of HRS-1167 | up to 24 months | |
| Recommended Phase II Dose (RP2D) of HRS-1167 | up to 24 months | |
| AEs+SAEs | from the first drug administration to within 30 days for the last treatment dose | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetic parameter of HRS-1167: Cmax | The concentration of HRS-1167 in plasma will be determined (Cmax will be derived). | At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) |
| Evaluation of pharmacokinetic parameter of HRS-1167: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanren Wang, M.D | Contact | +86 18036618570 | quanren.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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The concentration of HRS-1167 in plasma will be determined (Tmax will be derived). |
| At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) |
| Evaluation of pharmacokinetic parameter of HRS-1167: AUC | The concentration of HRS-1167 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. | At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) |
| Objective Response Rate (ORR) | Complete response + Partial response (CR+PR) based on RECIST 1.1. | up to 24 months |
| Disease control rate (DCR) | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1. | up to 24 months |
| Duration of response (DoR) | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. | up to 24 months |
| Progression Free Survival (PFS) | Time from C1D1 to first assessment of disease progression or death, whichever is earlier. | up to 24 months |
| Chongqing Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Guangxi Medical University Affiliated Tumor Hosipital | Recruiting | Nanning | Guangxi | 530021 | China |
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| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangzhou | 510120 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330209 | China |
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| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Liaoning Cancer Hospital | Recruiting | Shenyang | Liaoning | 110042 | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shangdong | 250062 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shangdong | 250117 | China |
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| Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030013 | China |
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| The Affiliated Hospital of Southwest Medical University | Recruiting | Luzhou | Sichuan | 646099 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhengjiang | 310022 | China |
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