drugset / Trial / NCT05102214

HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors

NCT05102214 ↗

Phase 1/2 Unknown 150 enrolled Shanghai Henlius Biotech
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX301 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has three parts: phase 1a dose escalation, phase 1b dose expansion, and phase 2 clinical expansion.

Timeline

Start
2022-05-03
Primary completion
2023-09-15
Completion
2024-02

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX301 Unknown 0.25 mg/kg Intravenous
Subject HLX301 Unknown 1 mg/kg Intravenous
Subject HLX301 Unknown 2.5 mg/kg Intravenous
Subject HLX301 Unknown 5 mg/kg Intravenous
Subject HLX301 Unknown 10 mg/kg Intravenous
Subject HLX301 Unknown 15 mg/kg Intravenous