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| Name | Class |
|---|---|
| Affiliated Hospital of Jiangnan University | OTHER |
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This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INN805 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INN805 | Drug | The drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine dose-limiting toxicity (DLT) | Determine the DLT of INN805 | 42 days after first dose |
| Frequency of adverse events (AEs) and SAEs | To investigate the safety characteristics of INN805 | Approximately 12 months |
| Determine the Maximum Tolerated Dose (MTD) | Determine the MTD of INN805 | Approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 | Approximately 12 months |
| Disease control rate (DCR) | DCR as assessed using RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingjin Wang | Contact | 18664044814 | wangtingjin@find-cure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
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| Approximately 12 months |
| Progression free survival (PFS) | PFS as assessed using RECIST 1.1 | Approximately 12 months |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013964 | Thyroid Neoplasms |
| D001943 | Breast Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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