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This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumabï¼› HRS-1167 | Drug | Bevacizumab: injection, 100mg(4mL), intravenous infusion HRS-1167: Tablets, 25mg/tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with dose-limiting toxicity (DLT) | From first dose of study treatment until the end of Cycle 1(up to 21 days) | |
| Determination of Recommended Phase II dose (RP2D) | From first dose of study treatment until the end of Cycle 1(up to 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria. | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)] |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Xu | Contact | 0518-82342973 | xin.xu@hengrui.com | |
| Yuting Wang | Contact | 0518-82342973 | yuting.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of University of Science and Technology of China | Not yet recruiting | Hefei | Anhui | 230002 | China |
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The percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 15 weeks after start of treatment |
| From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) |
| Duration of Response (DoR) | The time from the date of first response until date of disease progression or death in the absence of disease progression. | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) |
| Progression free Survival (PFS) | Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death | From time of fist dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) |
| Overall Survival (OS) | The time until death due to any cause. | From time of first dose of HRS-1167 or Bevacizumab until the date of death (up to 24 months) |
| Time To Response(TTR) | Time from C1D1 to complete or partial response, according to RECIST v1.1 criteria. | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) |
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Beijing Cancer Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| Guangxi Medical University Affiliated Tumor Hospital | Not yet recruiting | Nanning | Guangxi | 530022 | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050001 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Liaoning Cancer Hospital | Not yet recruiting | Shenyang | Liaoning | 110042 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Shandong First Medical University Affiliated Cancer Hospital | Not yet recruiting | Jinan | Shangdong | 250117 | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030006 | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | 610042 | China |
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| Tianjin Cancer Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650118 | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310005 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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