drugset / Trial / NCT05442996

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid Tumors

NCT05442996

Phase 1 Unknown 30 enrolled Shanghai Henlius Biotech
NaSequentialOpen-labelTreatment

Summary

This is a phase I clinical study designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of HLX35 in combination with HLX10 in patients with advanced or metastatic solid tumors.

Timeline

Start
2023-01-06
Primary completion
2024-04-22
Completion
2025-04-22

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX35 Unknown 0.1 mg/kg Intravenous
Subject HLX35 Unknown 0.3 mg/kg Intravenous
Subject HLX35 Unknown 1 mg/kg Intravenous
Subject HLX35 Unknown 3 mg/kg Intravenous
Subject HLX35 Unknown 10 mg/kg Intravenous
Subject Serplulimab Monoclonal antibody 200 mg Intravenous

Indications