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

NCT06940440 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-10-15

No results posted yet for this study

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

Interventions

DRUG

IFx-Hu2.0

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

DRUG

Pembrolizumab

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

Sponsors & Collaborators

  • TuHURA Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew S Brohl, MD · Collaborator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940440 on ClinicalTrials.gov