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| Name | Class |
|---|---|
| Guangzhou JOYO Pharma Co., Ltd | INDUSTRY |
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The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. The main questions it aims to answer are:
Participants will:
As this is a single-arm study, there is no comparison group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYP0035 monotherapy dose-escalation group | Experimental | PART-1 Single Dose Escalation Group |
|
| JYP0035 monotherapy dose-expansion group | Experimental | PART-2 JYP0035 Monotherapy Dose Expansion Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYP0035 Experimental Drug Treatment | Drug | Single dose intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the adverse event rate of this clinical trial | Grading the adverse events using National Cancer Institute - Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5.0. | From 8 weeks after the first administration up to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Area Under the Curve(AUC) | Area under the plasma concentration-time curve from zero to infinity | From 8 weeks after the first administration up to week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Jian, MD | Contact | 021-34778299 | 086 | Syner2000@163.com |
| Huang Hongming, MD | Contact | 028-85420509 | 086 | Honghm3@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 311215 | China |
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