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This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAX-10181 | Experimental | tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAX-10181 | Drug | Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence of treatment-related AEs | 8 weeks |
| Maximum tolerated dose (MTD) | MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing. | 4 weeks |
| Phase II dose (RP2D) | The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximum plasma concentration | Approximately 4 weeks |
| Cmax | Time to maximum plasma concentration | Approximately 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanying bao, MD,Ph.D | Contact | +86-021-51370693 | hybao@maxinovel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| AUC | Area under the time-concentration curve | Approximately 4 weeks |
| t1/2 | Observed terminal half-life | Approximately 4 weeks |
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | 12 months (anticipated) |