drugset / Trial / NCT05394168

A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors

NCT05394168

Phase 1 Unknown 12 enrolled Shanghai Henlius Biotech
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-09
Primary completion
2024-12-04
Completion
2025-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX53 Protein / enzyme biologic 30 mg Intravenous
Subject HLX53 Protein / enzyme biologic 150 mg Intravenous
Subject HLX53 Protein / enzyme biologic 400 mg Intravenous
Subject HLX53 Protein / enzyme biologic 1000 mg Intravenous
Subject HLX53 Protein / enzyme biologic 2000 mg Intravenous

Indications

No indication recorded.