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This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. |
|
| Dose Expansion | Experimental | Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-452080 | Drug | Subjects will receive BPI-452080 until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events (AEs) | Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events | Through the Phase I, approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration | Through the Phase I, approximately 24 months |
| Tmax | Time to reach maximum observed plasma concentration |
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Inclusion Criteria:
Arm1:has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2:Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3:Other solid tumors
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingwei Ye, Ph.D | Contact | 13701663571 | fuscc2012@163.com | |
| Jian Zhang, Ph.D | Contact | 13918273761 | Syner2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dingwei Ye, Ph.D | Fudan University | Principal Investigator |
| Jian Zhang, Ph.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 201321 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D006623 | von Hippel-Lindau Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Through the Phase I, approximately 24 months |
| t1/2 | Half-life time | Through the Phase I, approximately 24 months |
| the objective response rate(ORR) | The proportion of patients with complete response (CR) and partial response (PR) in all patients | Through the Phase I, approximately 24 months |
| Progression free survival (PFS) | The time from the date of randomization to disease progression (PD) or death, whichever occurs first | Through the Phase I, approximately 24 months |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
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| Zhejiang Cancer Hospital | Hangzhou | 310000 | China |
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| Hunan Cancer Hospital | Hunan | 410031 | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430000 | China |
|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D000798 | Angiomatosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000072661 | Ciliopathies |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |