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Trial Title:
A Study of BPI-452080 in Subjects With Solid Tumors
NCT ID:
NCT05843305
Condition:
Solid Tumor
Renal Cell Carcinoma
Von Hippel-Lindau Disease
Conditions: Official terms:
Carcinoma, Renal Cell
Von Hippel-Lindau Disease
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BPI-452080
Description:
Subjects will receive BPI-452080 until disease progression
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Summary:
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in
patients with Solid Tumors
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
201321
Country:
China
Contact:
Last name:
Dingwei Ye, Ph.D
Phone:
13701663571
Email:
fuscc2012@163.com
Contact backup:
Last name:
Jian Zhang, Ph.D
Phone:
13918273761
Email:
Syner2000@163.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Contact:
Last name:
Zhenhua Liu
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Meiyu Fang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Hunan
Zip:
410031
Country:
China
Contact:
Last name:
Shusuan Jiang
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Contact:
Last name:
Xiaoping Zhang
Start date:
April 28, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Betta Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Betta Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05843305
