NCT05341570

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

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668 in Advanced Solid Tumor Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BPI-21668	Subjects will receive BPI-21668 until disease progression

Timeline

• Start date: 2022-01-19
• Primary completion: 2024-01-31
• Completion: 2025-01-31
• First posted: 2022-04-22
• Last updated: 2022-04-22

Locations

1 site across 1 country: China