CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 7 enrolled
Drug / intervention
IFx-Hu2.0biological
Likely dose
IFx-Hu2.0 0.1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03655756
NCT03655756Early Ph 1Completed
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Phase 1 Study Using a Plasmid DNA Coding for Emm55 Streptococcal Antigen in Patients With Unresectable Stage III or Stage IV Cutaneous Melanoma

TuHURA Biosciences, Inc.·interventional·Posted Aug 31, 2018·Updated Aug 8, 2022

In Brief

A Early Phase 1 clinical trial evaluating IFx-Hu2.0 for Cutaneous Melanoma, Stage III and Cutaneous Melanoma, Stage IV. Completed, enrolled 7 participants across 1 site.

Detailed Summary

Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected). These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-7 business days for any delayed adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV
CountriesUnited States
CollaboratorsH. Lee Moffitt Cancer Center and Research Institute

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartNov 5, 2018
Primary CompletionJul 10, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.8 years ago

Interventions

IFx-Hu2.0biological

Subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at a single time point (28-day follow-up post last injection).