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NCT06940440 · ClinicalTrials.gov registry record · Phase 1
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
A Phase 1 study of Advanced Or Metastatic Merkel Cell Carcinoma, sponsored by TuHURA Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 2
- Study locations
NCT06940440: Recruiting Phase 1 study of Advanced Or Metastatic Merkel Cell Carcinoma, sponsored by TuHURA Biosciences.
NCT06940440 is a Phase 1 study of Advanced Or Metastatic Merkel Cell Carcinoma that is actively recruiting participants, run by TuHURA Biosciences. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06940440, a Phase 1 study of Advanced Or Metastatic Merkel Cell Carcinoma, is actively recruiting participants, sponsored by TuHURA Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG IFx-Hu2.0
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2025-10 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
What NCT06940440 shows while recruiting
NCT06940440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Advanced Or Metastatic Merkel Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06940440 reports a single indexed study location in Florida, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06940440 about?
NCT06940440 is a clinical study titled "IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)". 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 follow...
What is the current status of trial NCT06940440?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2025-10. Estimated completion is 2028-05-31.
What conditions does trial NCT06940440 study?
This clinical trial studies the following conditions: Advanced Or Metastatic Merkel Cell Carcinoma.
What interventions are being tested in trial NCT06940440?
The interventions under investigation include: Pembrolizumab (DRUG), IFx-Hu2.0 (DRUG).
Who is sponsoring clinical trial NCT06940440?
This trial is sponsored by TuHURA Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06940440 being conducted?
This trial has 2 study locations across Florida, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06940440's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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