A Study of BPI-452080 in Subjects With Solid Tumors
- Conditions
- Renal Cell CarcinomaSolid TumorVon Hippel-Lindau Disease
- Interventions
- Registration Number
- NCT05843305
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation BPI-452080 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 BPI-452080 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
- Primary Outcome Measures
Name Time Method adverse events (AEs) Through the Phase I, approximately 24 months Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events
- Secondary Outcome Measures
Name Time Method Cmax Through the Phase I, approximately 24 months Maximum observed concentration
Tmax Through the Phase I, approximately 24 months Time to reach maximum observed plasma concentration
t1/2 Through the Phase I, approximately 24 months Half-life time
the objective response rate（ORR） Through the Phase I, approximately 24 months The proportion of patients with complete response (CR) and partial response (PR) in all patients
Progression free survival (PFS) Through the Phase I, approximately 24 months The time from the date of randomization to disease progression (PD) or death, whichever occurs first
Trial Locations
- Locations (5)
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Hunan Cancer Hospital
🇨🇳Hunan, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, China