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

Part of paid clinical trials in Tampa, Florida.

Sponsor
TuHURA Biosciences, Inc.
Study ID
NCT06940440
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Or Metastatic Merkel Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Oct 2025
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Safety [ Time Frame: 28 days from last dose of IFx-Hu2.0 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612
Andrew S Brohl, MD
[email protected]
813-745-4673
Andrew S Brohl, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Ma Vincent, MD
[email protected]
800-622-8922
Ma Vincent, MD (PRINCIPAL_INVESTIGATOR)

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By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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