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Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR/DCR/DOR/TTR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study BPI-572270 in adults with specific RAS mutant advanced solid tumors | Experimental | Capsules; Administer once a day on an empty stomach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-572270 | Drug | Oral Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Number of Participants with Dose-Limiting Toxicity (DLT)AEs, including incidence and severity of findings in laboratory values and vital signs | up to 2 tears |
| RP2D | Determination of RP2D in the expansion phase | up to 2 tears |
| ORR | Further expand the inclusion to clarify the efficacy endpoint ORR | up to 3 tears |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Blood Concentration (Cmax) of BPI-572270 | up to 15 weeks |
| AUC | Area Under Blood Concentration Time Curve (AUC) of BPI-572270 |
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Inclusion Criteria:
Exclusion Criteria:
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| up to 15 weeks |
| Disease Control Rate (DCR) | up to 3 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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