Advanced Solid Tumor
Conditions
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.
Interventions
DRUGBPI-21668
Subjects will receive BPI-21668 until disease progression
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and ≤70 years, male and female patients; 2. Life expectancy ≥ 12 weeks; 3. ECOG performance score 0-1; 4. 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; 5. Evaluable lesion required for dose escalation phase and measurable lesion as per RECIST 1.1 required for dose expansion phase; 6. Adequate organ function; 7. Signed informed consent.
Exclusion criteria
1. Prior use of PI3K、mTOR or AKT inhibitor; 2. Prior other malignant tumor; 3. Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases ; 4. Type I or type II diabetes; 5. Inadequate wash-out of prior anti-cancer therapies; 6. Cardiac disorders; 7. Instable systemic diseases; 8. Acute or chronic pancreatitis; 9. Pregnancy or lactation; 10. Other protocol specified criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 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 (AEs). |
| Determine the Maximum Tolerated Dose (MTD) | Through the Phase I, approximately 24 months | The MTD will be based on DLT. |
| Determine the recommended Phase II dose (RP2D) | Through the Phase I, approximately 24 months | The RP2D will be based on DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pharmacokinetics of BPI-21668 | Through the Phase I, approximately 24 months | Based on blood plasma concentration |
| Determination of anti-tumor activity of BPI-21668 | Through the Phase I, approximately 24 months | Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 |
Countries
China
Contacts
Primary ContactBinghe Xu, Ph.D
Outcome results
None listed