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This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFH375 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFH375 | Drug | GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ia:The incidence and severity of AEs and SAEs | The incidence and severity of AEs and SAEs | 24 months |
| Phase Ia:The incidence of DLT events | The incidence of DLT events | 21 days |
| Phase Ib:The incidence and severity of AEs and SAEs | The incidence and severity of AEs and SAEs | 24 months |
| Phase II:Overall response rate (ORR) | For NSCLC cohort: Assessed by BICR according to RECIST 1.1;For other cohorts: Assessed by investigators according to RECIST 1.1; | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations | Plasma concentrations and PK parameters of GFH375 | up to 21 days |
| Efficacy endpoints | Duration of response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yolanda Zeng | Contact | +86 21 6882 1388 | yaozeng@genfleet.com |
| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, MD | Shanghai Chest Hospital | Principal Investigator |
| Aiping Zhou, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
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| 24 months |
| Efficacy endpoints | Disease control rate (DCR) | 24 months |
| Efficacy endpoints | Progression free survival (PFS) | 24 months |
| Efficacy endpoints | Overall survival (OS) | 24 months |
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| The Sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Haerbin | Heilongjiang | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
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| Liaoning Cancer Hospital & Institute | Not yet recruiting | Shenyang | Liaoning | China |
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| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | China |
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| Shanghai Chest Hospital | Recruiting | Shanhai | Shanghai Municipality | 201210 | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | China |
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| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjing | Tianjing | China |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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