A Study of BPI-452080 in Subjects With Solid Tumors
Solid Tumor, Renal Cell Carcinoma, Von Hippel-Lindau Disease
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists Dose expansion phase: 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 Adequate organ function Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase Exclusion Criteria: Has received prior treatment with another HIF-2α inhibitor Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor Pregnancy or lactation
Sites / Locations
- Fudan University Shanghai Cancer Center
- West China Hospital of Sichuan University
- Zhejiang Cancer Hospital
- Hunan Cancer Hospital
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dose Escalation
Dose Expansion
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.
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