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Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose exploration | Experimental | Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort |
|
| dose expansion | Experimental | dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-421286 | Drug | Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies | Number of subjects with treatment related adverse events | 20 months |
| determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen | Number of subjects with dose limiting toxicity | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics of BPI-421286 | Blood plasma concentration | 20 months |
| To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun Lu, Ph.D | Contact | 13601813062 | shun_lu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shun Lu, Ph.D | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
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Evaluate clinical activity/efficacy of BPI-421286
| 20 months |
| To evaluate the duration of response (DOR) in subjects with CR or PR as best response | Evaluate clinical activity/efficacy of BPI-421286 | 20 months |
| to evaluate the disease control rate (DCR) | Evaluate clinical activity/efficacy of BPI-421286 | 20 months |
| To evaluate progression-free survival (PFS) following initiation of BPI-421286 | Evaluate clinical activity/efficacy of BPI-421286 | 20 months |
| To evaluate overall (OS) following initiation of BPI-421286 | Evaluate clinical activity/efficacy of BPI-421286 | 20 months |
| Dingzhi Huang, Ph.D | Recruiting | Tianjin | Tianjin Municipality | China |
|
| Wen Li, Ph.D | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Yun Fan,Ph.D | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| Shun Lu, Ph.D | Recruiting | Shanghai | 200030 | China |
|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |