drugset
drugset / Trial / NCT05892718

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

NCT05892718 ↗

Phase 1 Recruiting 80 enrolled FBD Biologics Limited
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out whether IV injection of HCB101 is an effective treatment for different types of advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.

Timeline

Start
2023-10-02
Primary completion
2027-05-30
Completion
2029-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject HCB101 Protein / enzyme biologic 0.08 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 0.16 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 0.32 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 0.64 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 1.28 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 2.56 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 5.12 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 8 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 12 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 18 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 24 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 30 mg/kg Intravenous
Subject HCB101 Protein / enzyme biologic 36 mg/kg Intravenous

Indications

non-Hodgkin lymphoma