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
Not provided
The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-65mg QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR790 | Drug | Subjects will receive oral administration of BR790. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | up to 32 day | |
| maximum tolerated dose (MTD) | up to 32 day | |
| recommended phase II clinical study dose (RP2D) | up to 32 day |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | up to 32 day | |
| Cmax | up to 32 day | |
| t1/2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 32 day |
| pERK | the level of pERK in blood | up to 32 day |
| AE | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | through study completion, an average of 3 years |
| ORR | through study completion, an average of 3 years |