IFx-Hu2.0

BIOLOGICAL6 trials

Conditions

Advanced Or Metastatic Merkel Cell CarcinomaBasal Cell CarcinomaCutaneous Melanoma, Stage IIICutaneous Melanoma, Stage IVCutaneous Squamous Cell CarcinomaMerkel Cell CarcinomaNon-Melanoma Skin Cancers

Early Phase 1

pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma

CompletedNCT03655756

TuHURA Biosciences, Inc.Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV

Start: 2018-11-05End: 2020-11-30Updated: 2022-08-08

Phase 1

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers

CompletedNCT04160065

TuHURA Biosciences, Inc.Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Non-Melanoma Skin Cancers

Start: 2020-03-03End: 2024-08-13Updated: 2024-09-23

IFx-Hu2.0 for the Treatment of Patients With Skin Cancer

CompletedNCT04925713

TuHURA Biosciences, Inc.Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma

Start: 2021-06-10End: 2022-03-10Updated: 2024-08-02

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

RecruitingNCT06940440

TuHURA Biosciences, Inc.Advanced Or Metastatic Merkel Cell Carcinoma

Start: 2025-10-31End: 2028-05-31Target: 9Updated: 2025-10-15

Phase 2

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

RecruitingNCT06947928

TuHURA Biosciences, Inc.Advanced Or Metastatic Merkel Cell Carcinoma

Start: 2025-12-11End: 2032-12-30Target: 118Updated: 2026-04-17

Unknown Phase

IFx-Hu2.0 Expanded Access Program

NCT04853602

TuHURA Biosciences, Inc.Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Cutaneous Squamous Cell Carcinoma +1

Updated: 2024-08-12

Journal of Clinical Oncology2024-06-011 citations

Phase 1b trial of IFx-Hu2.0, a novel personalized cancer vaccine, in checkpoint inhibitor resistant merkel cell carcinoma and cutaneous squamous cell carcinoma.

Journal of Clinical Oncology2023-06-016 citations

Abstract 5199: Tumor-specific antibody response induced by novel immunomodulator, IFx-Hu2.0, reflects extent of epitope spreading to multiple tumor epitopes

Cancer Research2022-06-15

IFx-Hu2.0 phase I first in human study for unresectable melanoma for an intralesional “in-situ vaccine” approach.

Journal of Clinical Oncology2022-06-015 citations

Abstract CT241: Trial in progress: IFx-Hu2.0 (plasmid DNA coding for Emm55 streptococcal antigen in a cationic polymer) phase I first in human study for unresectable stage III or stage IV cutaneous melanoma

Cancer Research2020-08-153 citations

Abstract CT119: Trial in progress: First in human Phase I study using a plasmid DNA coding for Emm55 streptococcal antigen (IFx-Hu2.0) in patients with unresectable stage III or stage IV cutaneous melanoma

Cancer Research2019-07-013 citations

Clinical Trials2019-07-012 citations