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| Name | Class |
|---|---|
| Shanghai Xianwei Medical Technology Co., Ltd. | UNKNOWN |
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This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIM0689 for Injection | Experimental | One intravenous infusion of SIM0689 for Injection, 28 days or 21 days as a treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0689 for Injection | Drug | SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) (Dose escalation) | DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria. | at the end of Cycle 1 (each cycle is 28 days) |
| Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation) | The MTD is defined as the dose of SIM0689 with an estimated toxicity rate closest to the target toxicity rate of 27%ï¼› RD stands for Recommended Dose, which will be selected based on the evaluation of all available pharmacokinetics, pharmacodynamic, efficacy, safety, and tolerability data | Up to approximately 2 years |
| Objective Response Rate (ORR) (Dose expansion) | ORR is the proportion of participants with complete response(CR)or partial response (PR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 6.0. | up to approximately 2 years |
| Pharmacokinetics: The area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingbo Liang | Contact | +86 13666676121 | liangtingbo_trial@163.com | |
| Xueli Bai | Contact | baixueli_trial@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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The area under the curve (AUC) of serum concentration of SIM0689
| up to approximately 2 years |
| Pharmacokinetics: Peak concentration (Cmax) | Maximum observed concentration (Cmax) of SIM0689 | Up to approximately 2 years |
| Pharmacokinetics: T1/2 | Terminal half-life (T1/2) | Up to approximately 2 years |
| Pharmacokinetics: Tmax | Time to maximum concentration | Up to approximately 2 years |
| Immunogenicity | Titer of serum anti-SIM0689 antibodies | Up to approximately 2 years |
| Immunogenicity | Incidence rate of serum anti-SIM0689 antibodies | Up to approximately 2 years |
| Immunogenicity | Duration of serum anti-SIM0689 antibodies | Up to approximately 2 years |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
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| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
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| Cancer Hospital of Shandong First Medical University | Jinan | Shandong | 250117 | China |
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| The First Affiliated Hospital, Zhejiang University school of Medicine | Hangzhou | Zhejiang | 310003 | China |
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