drugset
drugset / Trial / NCT05322408

HCW9218 in Select Advanced Solid Tumors

NCT05322408 ↗

Phase 1 Completed 18 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, Phase I dose finding study of HCW9218 for the treatment of advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers). HCW9218 is a novel bi-functional fusion protein complex administered by subcutaneous (SC) injection. It is comprised of a soluble fusion of two human TGFβRII domains, human tissue factor, and human IL-15, and a second soluble fusion of two human TGFβRII domains and a sushi domain of human IL-15Rα. HCW9218 activates IL-15R signaling on effector immune cells and the dimeric TGFβRII functions as a "trap" for all three human TGF-β isoforms.

Timeline

Start
2022-04-01
Primary completion
2025-01-02
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject HCW9218 Protein / enzyme biologic 0.1 mg/kg Subcutaneous
Subject HCW9218 Protein / enzyme biologic 0.25 mg/kg Subcutaneous
Subject HCW9218 Protein / enzyme biologic 0.5 mg/kg Subcutaneous
Subject HCW9218 Protein / enzyme biologic 0.8 mg/kg Subcutaneous
Subject HCW9218 Protein / enzyme biologic 1.2 mg/kg Subcutaneous

Indications

cancer