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

October 10, 2025 updated by: TuHURA Biosciences, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center and Research Institute
        • Contact:
        • Principal Investigator:
          • Andrew S Brohl, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
        • Principal Investigator:
          • Ma Vincent, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. Life expectancy equal to or greater than six months.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
  4. Active disease measurable by CT or MRI, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded).

  5. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma

    a. Must have at least one visceral injectable lesion equal to or greater than 3 mm

  6. Subject should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
  7. Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
  8. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

Exclusion Criteria

  1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
  2. Subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids.
  3. Subjects with recurrent resectable MCC
  4. Subjects who have received prior systemic chemotherapy
  5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
  6. Active, known, or suspected autoimmune disease. Potential subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low grade autoimmune toxicity is NOT an exclusion under this criterion.
  7. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of IFx-Hu2.0 administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IFx-Hu2.0
Subjects will receive IFx-Hu2.0 (0.1 mg) as a visceral lesion injection in a single lesion once per week for three consecutive weeks. KEYTRUDA® (pembrolizumab) (200 mg) will be administered intravenously (IV) on Visit 1 (within 48 hours from the first IFx-Hu2.0 injection) then every three weeks for approximately six months, until disease progression or unacceptable immune related toxicity.
Drug: IFx-Hu2.0

Therapeutic Classification:

• Innate immune agonist

Route of Administration:

• Intralesional

Other Names:
  • pAc/emm55
Drug: Pembrolizumab

Therapeutic Classification:

• Immunotherapy (Immune checkpointinhibitor)

Route of administration:

• Intravenous (IV) infusion

Other Names:
  • KEYTRUDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 28 days from last dose of IFx-Hu2.0
Safety is defined as the absence of any grade 3-5, treatment-related Adverse Events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from first injection Day 1 to 28-day follow-up after the final dose of IFx-Hu2.0.
28 days from last dose of IFx-Hu2.0
Feasibility
Time Frame: 28 days from last dose of IFx-Hu2.0
Feasibility is defined as the ability to treat ≥50% of subjects (i.e. 5/9) in the per-protocol analysis.
28 days from last dose of IFx-Hu2.0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TuHURA Biosciences, Inc.

Investigators

  • Principal Investigator: Andrew S Brohl, MD, Collaborator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC 2023-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Or Metastatic Merkel Cell Carcinoma

Clinical Trials on IFx-Hu2.0

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe