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NCT06940440
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint Inhibitor Naïve Subjects With Advanced Or Metastatic Merkel Cell Carcinoma
Phase 1 trial testing IFx-Hu2.0 in Advanced Or Metastatic Merkel Cell Carcinoma in 9 participants. Currently enrolling.
31 May 2026
Quick facts
| Lead sponsor | TuHURA Biosciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 October 2025 |
| Primary completion | 31 May 2026 |
| Estimated completion | 31 May 2028 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- IFx-Hu2.0 — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Advanced Or Metastatic Merkel Cell Carcinoma — all drugs for Advanced Or Metastatic Merkel Cell Carcinoma →
Sponsor
TuHURA Biosciences, Inc. — full company profile →
Who can join
18 and older, any sex, with Advanced Or Metastatic Merkel Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety
Time frame: 28 days from last dose of IFx-Hu2.0
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. -
Feasibility
Time frame: 28 days from last dose of IFx-Hu2.0
Feasibility is defined as the ability to treat ≥50% of subjects (i.e. 5/9) in the per-protocol analysis.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06940440
- 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
- NCT04160065 — Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers · 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 Advanced Or Metastatic Merkel Cell Carcinoma
Currently open trials in the same condition.
- NCT06947928 — Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced · Phase 2, PHASE3 · 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
- NCT04160065 — Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers · 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 NCT06940440 (US National Library of Medicine, public domain)
- 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: 10 October 2025
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/NCT06940440.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing