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This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Experimental | Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia). Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib). |
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| Phase II | Experimental | Patients receive BPI-361175 based on RP2D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-361175 | Drug | Subjects will receive BPI-361175 until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: The adverse events (AEs) | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs). | Through the Phase I, approximately 24 months |
| Phase I: Determine the recommended Phase II dose (RP2D) | Number of subjects with dose limiting toxicity | Through the Phase I, approximately 24 months |
| Phase II: the objective response rate (ORR) | The proportion of patients with complete response (CR) and partial response (PR) in all patients. | Through the Phase II, approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Evaluate the pharmacokinetics of BPI-361175 | Blood plasma concentration | Through the Phase I, approximately 24 months |
| Phase I: the objective response rate (ORR) | The proportion of patients with complete response (CR) and partial response (PR) in all patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caicun Zhou, Ph.D | Contact | 021-65115006 | fkzlkzhoudr@126.com | |
| Jianying Zhou, Ph.D | Contact | 0571-87236114 | drzjy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou, Ph.D | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Jianying Zhou, Ph.D | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Through the Phase I, approximately 24 months |
| Phase II: Disease control rate (DCR) | The proportion of patients with CR, PR and stable disease (SD) in all patients. | Through the Phase II, approximately 24 months |
| Phase II: Progression free survival (PFS) | The time from the first study dose to disease progression (PD) or death, whichever occurs first. | Through the Phase II, approximately 24 months |
| Phase II: Overall survival (OS) | The time from the first study dose to death due to any cause. | Through the Phase II, approximately 24 months |
| Phase II: Duration of response (DOR) | The time from the first CR or PR to the first PD or death due to any cause. | Through the Phase II, approximately 24 months |
| Phase II: The adverse events (AEs) | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs). | Through the Phase II, approximately 24 months |
| Phase I: Disease control rate (DCR) | The proportion of patients with CR, PR and stable disease (SD) in all patients. | Through the Phase I, approximately 24 months |
| Phase I: Progression free survival (PFS) | The time from the first study dose to disease progression (PD) or death, whichever occurs first. | Through the Phase I, approximately 24 months |
| Phase I: Overall survival (OS) | The time from the first study dose to death due to any cause. | Through the Phase I, approximately 24 months |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
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| Hunan cancer hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| the First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |