drugset / Trial / NCT05341570

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668

NCT05341570 ↗

Phase 1 Unknown 60 enrolled Betta Pharmaceuticals Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject BPI-21668 Unknown — Oral

Indications