A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors
- Registration Number
- NCT05302843
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
- At least 18 years of age
- Measurable or evaluable disease
- Adequate organ function as defined per protocol
Exclusion Criteria
- Symptomatic or unstable brain metastases
- Pregnancy or lactation
- Other protocol specified criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dose exploration and dose expansion BPI-28592 Patients receive BPI-28592 PO. Cycles repeat every 28 days.
- Primary Outcome Measures
Name Time Method Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies about 20 months Number of subjects with treatment related adverse events
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen about 20 months Number of subjects with dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Evaluate the pharmacokinetics of BPI-28592 about 20 months Blood plasma concentration
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592 about 20 months Evaluate clinical activity/efficacy of BPI-28592
To evaluate the duration of response (DOR) in subjects with CR or PR as best response about 20 months Evaluate clinical activity/efficacy of BPI-28592
to evaluate the disease control rate (DCR) about 20 months Evaluate clinical activity/efficacy of BPI-28592
To evaluate progression-free survival (PFS) following initiation of BPI-28592 about 20 months Evaluate clinical activity/efficacy of BPI-28592
To evaluate overall (OS) following initiation of BPI-28592 about 20 months Evaluate clinical activity/efficacy of BPI-28592
Trial Locations
- Locations (1)
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
🇨🇳HangZhou, Zhejiang, China