CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 60 target
Drug / intervention
BPI-21668drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05341570
NCT05341570Phase 1Unknown

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

Betta Pharmaceuticals Co., Ltd.·interventional·Posted Apr 22, 2022·Updated Apr 22, 2022

In Brief

A Phase 1 clinical trial evaluating BPI-21668 for Advanced Solid Tumor. Targeting 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
20222023202420252026
First PostedApr 22, 2022
Enrollment StartJan 19, 2022
Primary CompletionJan 31, 2024
Study CompletionJan 31, 2025
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 4.2 years ago

Interventions

BPI-21668drug

Subjects will receive BPI-21668 until disease progression