At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 300 enrolled
Drug / intervention
Tislelizumabdrug
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.
Phase I/II Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activities of Anti-PD-1 Monoclonal Antibody BGB-A317 in Chinese Patients With Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating Tislelizumab for Advanced Solid Tumors. Completed, enrolled 300 participants across 12 sites.
Detailed Summary
This was a dose verification, pharmacokinetic (PK) assessment of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP; FMP: Final Manufacturing Process) and indication expansion clinical study of monoclonal antibody conducted in Chinese subjects with advanced solid tumors, with a purpose of exploring the safety, tolerability, pharmacokinetics and preliminary efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
Primary CompletionDec 2018
First PostedAug 2019
Study CompletionMay 2020
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartDec 28, 2016
Primary CompletionDec 1, 2018
Study CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.8 years ago
Interventions
Tislelizumabdrug
Administered intravenously