drugset / Trial / NCT05341570
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2022-01-19
- Primary completion
- 2024-01-31
- Completion
- 2025-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BPI-21668 | Unknown | — | Oral |