drugset / Trial / NCT05606380

A Phase I Study to Investigate the Safety, Tolerability and PK of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Solid Tumors or Lymphoma

NCT05606380

Phase 1 Unknown 11 enrolled Shanghai Henlius Biotech
NaSingle-groupOpen-labelTreatment

Summary

This trial is an open, dose escalation phase I clinical study. Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX60 intravenous infusion, every 3 weeks, treatment until lose clinical benefit, toxicity, death, revocation of informed consent.

Timeline

Start
2022-12-02
Primary completion
2024-08
Completion
2025-02

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX60 Monoclonal antibody 0.5 mg/kg Intravenous
Subject HLX60 Monoclonal antibody 2 mg/kg Intravenous
Subject HLX60 Monoclonal antibody 5 mg/kg Intravenous
Subject HLX60 Monoclonal antibody 15 mg/kg Intravenous
Subject HLX60 Monoclonal antibody 25 mg/kg Intravenous

Indications