Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX005425 | Experimental | Subjects will take a pre-specified dose of JMKX005425. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX005425 | Drug | JMKX005425 administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs) | To assess the safety and tolerability of JMKX005425. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration (Cmax) | Maximum observed concentration. | Up to 2 months |
| maximum plasma concentration (Tmax) | Time to reach maximum observed plasma concentration. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Chen | Contact | +86 17717684840 | chenlu5@jeyoupharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2 months |
| 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 2 years |
| Disease Control Rate (DCR) | DCR is the percentage of patients with a best overall response of CR or PR or Stable Disease (SD) per RECIST v1.1. | Up to 2 years |