Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
87 participants
INTERVENTIONAL
2023-04-28
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
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.
BPI-452080
Subjects will receive BPI-452080 until disease progression
Dose Expansion
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
BPI-452080
Subjects will receive BPI-452080 until disease progression
Interventions
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BPI-452080
Subjects will receive BPI-452080 until disease progression
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dingwei Ye, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Jian Zhang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Hunan Cancer Hospital
Hunan, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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Zhenhua Liu
Role: primary
Meiyu Fang
Role: primary
Shusuan Jiang
Role: primary
Xiaoping Zhang
Role: primary
Other Identifiers
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BTP-661811
Identifier Type: -
Identifier Source: org_study_id
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