At a glance
ClinicalIndex Comparison RecordPhase 2Unknown· 90 target
Drug / intervention
BPI-361175drug
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.
A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating BPI-361175 for Non-small Cell Lung Cancer. Targeting 90 participants across 8 sites.
Detailed Summary
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 2UnknownOverdue
20222023202420252026
Enrollment StartJul 2021
First PostedApr 2022
Primary CompletionJun 2023
Study CompletionDec 2023
TodayJul 2026
First PostedApr 15, 2022
Enrollment StartJul 21, 2021
Primary CompletionJun 30, 2023
Study CompletionDec 31, 2023
TodayJul 1, 2026
Enrollment to primary: 1.9 yearsPosted 4.2 years ago
Interventions
BPI-361175drug
Subjects will receive BPI-361175 until disease progression