Status:
UNKNOWN
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05341570
Start Date
January 19 2022
End Date
January 31 2025
Last Update
April 22 2022
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021