At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 259 enrolled
Drug / intervention
CS1001drug
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 Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating CS1001 for Advanced Cancer. Completed, enrolled 259 participants across 2 sites.
Detailed Summary
This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartOct 2017
Primary CompletionAug 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedOct 18, 2017
Enrollment StartOct 19, 2017
Primary CompletionAug 16, 2021
Study CompletionFeb 16, 2022
TodayJul 1, 2026
Enrollment to primary: 3.8 yearsPosted 8.7 years ago
Interventions
CS1001drug
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.