RecruitingPhase 1NCT06940440

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


Sponsor

TuHURA Biosciences, Inc.

Enrollment

9 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing IFx-Hu2.0, a new drug injected directly into tumors, combined with the immunotherapy drug pembrolizumab for patients with advanced Merkel cell carcinoma — a rare and aggressive skin cancer. **You may be eligible if...** - You are 18 or older - You have confirmed Stage III or IV Merkel cell carcinoma that cannot be surgically removed - You have at least one tumor that can be directly injected and is 3 mm or larger - You have never received any checkpoint immunotherapy (such as pembrolizumab, avelumab, or nivolumab) - Your overall health and organ function meet the required thresholds - Your life expectancy is at least 6 months **You may NOT be eligible if...** - You have previously received checkpoint immunotherapy - You have active autoimmune disease requiring systemic treatment - You have severe organ dysfunction or active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIFx-Hu2.0

Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional

DRUGPembrolizumab

Therapeutic Classification: • Immunotherapy (Immune checkpointinhibitor) Route of administration: • Intravenous (IV) infusion


Locations(2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06940440


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