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This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose exploration and dose expansion | Experimental | Patients receive BPI-28592 PO. Cycles repeat every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-28592 | Drug | Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies | Number of subjects with treatment related adverse events | about 20 months |
| determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen | Number of subjects with dose limiting toxicity | about 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics of BPI-28592 | Blood plasma concentration | about 20 months |
| To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongming Pan, Ph.D | Contact | 0571-86006922 | shonco@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39256512 | Derived | Sheng J, Chen H, Fu B, Pan H, Wang J, Han W. BPI-28592 as a novel second generation inhibitor for NTRK fusion tumors. NPJ Precis Oncol. 2024 Sep 11;8(1):198. doi: 10.1038/s41698-024-00686-8. |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Evaluate clinical activity/efficacy of BPI-28592
| about 20 months |
| To evaluate the duration of response (DOR) in subjects with CR or PR as best response | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months |
| to evaluate the disease control rate (DCR) | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months |
| To evaluate progression-free survival (PFS) following initiation of BPI-28592 | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months |
| To evaluate overall (OS) following initiation of BPI-28592 | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months |