drugset / Trial / NCT05360680

A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

NCT05360680 ↗

Phase 1 Completed 42 enrolled Cue Biopharma
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A\*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.

Timeline

Start
2022-06-14
Primary completion
2025-03-12
Completion
2025-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CUE-102 Protein / enzyme biologic 1 mg/kg Intravenous
Subject CUE-102 Protein / enzyme biologic 2 mg/kg Intravenous
Subject CUE-102 Protein / enzyme biologic 4 mg/kg Intravenous
Subject CUE-102 Protein / enzyme biologic 8 mg/kg Intravenous