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NCT04160065
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers
Phase 1 trial testing IFx-Hu2.0 in Merkel Cell Carcinoma in 23 participants. Completed in 13 August 2024.
19 October 2023
Quick facts
| Lead sponsor | TuHURA Biosciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 3 March 2020 |
| Primary completion | 19 October 2023 |
| Estimated completion | 13 August 2024 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- IFx-Hu2.0 — full drug profile →
Conditions studied
- Merkel Cell Carcinoma — all drugs for Merkel Cell Carcinoma →
- Cutaneous Squamous Cell Carcinoma — all drugs for Cutaneous Squamous Cell Carcinoma →
- Non-Melanoma Skin Cancers — all drugs for Non-Melanoma Skin Cancers →
Sponsor
TuHURA Biosciences, Inc. — full company profile →
Who can join
18 and older, any sex, with Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced non-melanoma skin cancers will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up to three lesions at up to three time points. Subjects will be observed for any acute adverse events (AEs) post injection and for any delayed AEs at Day 28, 35 and/or 42 ± 7 days, depending on the cohort (exposure escalation and expansion design).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trial watch: intratumoral immunotherapy.
Humeau J, Le Naour J, Galluzzi L, Kroemer G, et al · · 2021 · cited 45× · PMID 34676147 · DOI 10.1080/2162402x.2021.1984677 -
Merkel Cell Carcinoma: New Trends.
Zwijnenburg EM, Lubeek SFK, Werner JEM, Amir AL, et al · · 2021 · cited 31× · PMID 33807446 · DOI 10.3390/cancers13071614 -
Landscape and Future Perspectives of Immunotherapy in Neuroendocrine Neoplasia.
Maggio I, Manuzzi L, Lamberti G, Ricci AD, et al · · 2020 · cited 30× · PMID 32235636 · DOI 10.3390/cancers12040832 -
Immunotherapy for the Treatment of Cutaneous Squamous Cell Carcinoma.
Boutros A, Cecchi F, Tanda ET, Croce E, et al · · 2021 · cited 28× · PMID 34513710 · DOI 10.3389/fonc.2021.733917 -
How we treat Merkel cell carcinoma: within and beyond current guidelines.
Park SY, Doolittle-Amieva C, Moshiri Y, Akaike T, et al · · 2021 · cited 25× · PMID 33511866 · DOI 10.2217/fon-2020-1036 -
Merkel Cell Carcinoma-Update on Diagnosis, Management and Future Perspectives.
Zaggana E, Konstantinou MP, Krasagakis GH, de Bree E, et al · · 2022 · cited 23× · PMID 36612102 · DOI 10.3390/cancers15010103 -
Beyond Lipids: Exploring Advances in Polymeric Gene Delivery in the Lipid Nanoparticles Era.
Jogdeo CM, Siddhanta K, Das A, Ding L, et al · · 2024 · cited 22× · PMID 38842816 · DOI 10.1002/adma.202404608 -
Merkel Cell Carcinoma from Molecular Pathology to Novel Therapies.
Stachyra K, Dudzisz-Śledź M, Bylina E, Szumera-Ciećkiewicz A, et al · · 2021 · cited 21× · PMID 34208339 · DOI 10.3390/ijms22126305
Verify or expand the search:
- PubMed search for NCT04160065
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IFx-Hu2.0
Trials testing the same drug.
- NCT06947928 — Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced · Phase 2, PHASE3 · recruiting
- NCT04925713 — IFx-Hu2.0 for the Treatment of Patients With Skin Cancer · Phase 1 · completed
- NCT03655756 — pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma · EARLY_PHASE1 · completed
- NCT04853602 — IFx-Hu2.0 Expanded Access Program · available
Other recruiting trials for Merkel Cell Carcinoma
Currently open trials in the same condition.
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- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
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- NCT06753136 — Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histo · NA · recruiting
- NCT06223659 — EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigra · Phase 2 · recruiting
Other TuHURA Biosciences, Inc. trials
Trials by the same sponsor.
- NCT06947928 — Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced · Phase 2, PHASE3 · recruiting
- NCT04925713 — IFx-Hu2.0 for the Treatment of Patients With Skin Cancer · Phase 1 · completed
- NCT03655756 — pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma · EARLY_PHASE1 · completed
- NCT04853602 — IFx-Hu2.0 Expanded Access Program · available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04160065 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TuHURA Biosciences, Inc.
- Last refreshed: 23 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04160065.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing