At a glance
ClinicalIndex Comparison RecordPhase 1Unknown· 12 enrolled
Drug / intervention
HLX53biological
Likely dose
HLX53 30mgfrom 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 I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX53 (an Anti-TIGIT Fc Fusion Protein) in Patients With Advanced/Metastatic Solid Tumors
In Brief
A Phase 1 clinical trial evaluating HLX53 for Advanced/Metastatic Solid Tumors. Targeting 12 participants across 1 site.
Detailed Summary
This phase I, first-in-human, open-label clinical study will evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX53 (an anti-TIGIT Fc fusion protein) in patients with advanced/metastatic solid tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced/Metastatic Solid Tumors
CountriesChina
Collaborators--
Timeline
Phase 1UnknownOverdue
2023202420252026
First PostedMay 2022
Enrollment StartDec 2022
Primary CompletionDec 2024
Study CompletionMar 2025
TodayJul 2026
First PostedMay 27, 2022
Enrollment StartDec 9, 2022
Primary CompletionDec 4, 2024
Study CompletionMar 4, 2025
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 4.1 years ago
Interventions
HLX53biological
There are 5 preset dose groups, namely 30mg/QW, 150mg/QW, 400mg/QW, 1000mg/Q3W and 2000mg/Q3W, administered by intravenous infusion.