drugset / Trial / NCT06940440

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)

NCT06940440

Phase 1 Recruiting 9 enrolled TuHURA Biosciences, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine subjects will receive IFx-Hu2.0 as a visceral lesion injection in a single lesion followed by pembrolizumab.

Timeline

Start
2025-10
Primary completion
2026-05-31
Completion
2028-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject IFx-Hu2.0 Vaccine 0.1 mg Other
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous