A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668 in Advanced Solid Tumor Patients
Overview
- Phase
- Phase 1
- Intervention
- BPI-21668
- Conditions
- Advanced Solid Tumor
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Determine the Maximum Tolerated Dose (MTD)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients. In dose escalation phase, biomarker status is not required, but in dose expansion phase patients are required to harbor PIK3CA mutation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 and ≤70 years, male and female patients;
- •Life expectancy ≥ 12 weeks;
- •ECOG performance score 0-1;
- •Locally advanced or relapsed/metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy or for whom no standard therapy exists, PIK3CA mutation status is required for dose expansion phase;
- •Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase;
- •Adequate organ function;
- •Signed informed consent.
Exclusion Criteria
- •Prior use of PI3K、mTOR or AKT inhibitor;
- •Prior other malignant tumor;
- •Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ;
- •Type I or type II diabetes;
- •Inadequate wash-out of prior anti-cancer therapies;
- •Cardiac disorders;
- •Instable systemic diseases;
- •Acute or chronic pancreatitis;
- •Pregnancy or lactation;
- •Other protocol specified criteria.
Arms & Interventions
Dose Escalation
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).
Intervention: BPI-21668
Dose Expansion
Oral tablets administered at MTD/RP2D. Each treatment cycle will be 28 days in duration with BPI-21668 administered, once daily (QD).
Intervention: BPI-21668
Outcomes
Primary Outcomes
Determine the Maximum Tolerated Dose (MTD)
Time Frame: Through the Phase I, approximately 24 months
The MTD will be based on DLT.
The adverse events (AEs)
Time Frame: Through the Phase I, approximately 24 months
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Determine the recommended Phase II dose (RP2D)
Time Frame: Through the Phase I, approximately 24 months
The RP2D will be based on DLT.
Secondary Outcomes
- Determination of anti-tumor activity of BPI-21668(Through the Phase I, approximately 24 months)
- Evaluate the pharmacokinetics of BPI-21668(Through the Phase I, approximately 24 months)