Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06940440

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

Led by TuHURA Biosciences, Inc. · Updated on 2025-10-15

9

Participants Needed

2

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age.
  • Life expectancy equal to or greater than six months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.
  • Active disease measurable by CT or MRI with lesions measurable in at least one dimension.
  • Recurrent and/or unresectable Stage III or Stage IV Merkel cell carcinoma confirmed by histology.
  • At least one visceral injectable lesion equal to or greater than 3 mm.
  • No prior treatment with immune checkpoint inhibitors including pembrolizumab, avelumab, ipilimumab, or nivolumab.
  • Tumor tissue available from archival biopsy or new biopsy for biomarker analysis.
  • Adequate blood, liver, and kidney function as defined by study protocol.
Not Eligible

You will not qualify if you...

  • Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance.
  • Active brain metastases except treated, stable brain metastases without new lesions or steroid requirement.
  • Recurrent resectable Merkel cell carcinoma.
  • Prior systemic chemotherapy.
  • Pregnant or breastfeeding females or those planning pregnancy or breastfeeding during the study.
  • Active, known, or suspected autoimmune disease, except certain conditions not requiring systemic treatment.
  • Need for systemic corticosteroids over 10 mg prednisone equivalent or other immunosuppressive drugs within 14 days before IFx-Hu2.0 administration. Inhaled or topical steroids allowed if no active autoimmune disease.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Actively Recruiting

2

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

J

James Bianco, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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