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| Name | Class |
|---|---|
| Zhejiang Hangyu Pharmaceutical Co., Ltd. | INDUSTRY |
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This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Subjects will be assigned to pre-specified dose level to determine MTD/MAD of JMKX003948. Each treatment cycle will be 21 days. |
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| Dose Expansion | Experimental | Subjects will be assigned to the recommended dose level determined in dose escalation Phase. Each treatment cycle will be 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003948 | Drug | Subjects will receive JMKX003948 tablets until disease progression |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Number of participants with dose limiting toxicities (DLTs) | Number of participants with DLTs | Up to 2 months |
| Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Number of participants with AEs/SAEs to characterize the safety and tolerability of JMKX003948. | Up to 2 years |
| Dose Expansion: Objective Response Rate (ORR) | ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration (Cmax) | Maximum observed concentration. | Up to 1 month |
| maximum plasma concentration (Tmax) | Time to reach maximum observed plasma concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huihui Xiang | Contact | +86 15928607671 | xianghuihui@jemincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Caancer Hospital | Recruiting | Beijing | China |
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| Up to 1 month |
| Duration of Response (DoR) | DoR is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first. | Up to 1 year |