Advanced Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGBR790
Subjects will receive oral administration of BR790.
Sponsors
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Sign informed consent voluntarily. * Age ≥18 and ≤75 years old. * Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment. * Had at least one measurable lesion. * ECOG≤1. * Expected survival period ≥ 3 months.
Exclusion criteria
* Any previous treatment with SHP-2 inhibitor. * Symptomatic brain metastases. * Subjects with thoracic/ascites fluid that need drainage or intervention. * Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN. * With uncontrolled severe disease.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pERK | up to 32 day | the level of pERK in blood |
| AUC | up to 32 day | — |
| ORR | through study completion, an average of 3 years | — |
| AE | through study completion, an average of 3 years | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Cmax | up to 32 day | — |
| t1/2 | up to 32 day | — |
Outcome results
None listed