NCT06940440

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

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint Inhibitor Naïve Subjects With Advanced Or Metastatic Merkel Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: TuHURA Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Or Metastatic Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	IFx-Hu2.0	Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
DRUG	Pembrolizumab	Therapeutic Classification: • Immunotherapy (Immune checkpointinhibitor) Route of administration: • Intravenous (IV) infusion

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-05-31
• Completion: 2028-05-31
• First posted: 2025-04-23
• Last updated: 2025-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study