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

NCT06940440 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MCC 2023-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Metastatic; Advanced; Merkel Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Safety

  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

  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

Study Arms (1)

IFx-Hu2.0

EXPERIMENTAL

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; Drug: Pembrolizumab

Interventions

IFx-Hu2.0 DRUG

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

Also known as: pAc/emm55

IFx-Hu2.0

Pembrolizumab DRUG

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

Also known as: KEYTRUDA

IFx-Hu2.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Life expectancy equal to or greater than six months.
• Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2.
• 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).
• 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
• Subject should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
• 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.
• Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

You may not qualify if:

• 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.
• 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.
• Subjects with recurrent resectable MCC
• Subjects who have received prior systemic chemotherapy
• Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
• 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.

Sponsors & Collaborators

• TuHURA Biosciences, Inc.: lead

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Merkel Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Andrew S Brohl, MD

  Collaborator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Bianco, MD

CONTACT

8138756600; jbianco@tuhurabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 23, 2025
• Study Start: October 1, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (2)