NCT06940440 IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
| NCT ID | NCT06940440 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | TuHURA Biosciences, Inc. |
| Condition | Advanced Or Metastatic Merkel Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2026-01-27 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 participant (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine participants will receive IFx-Hu2.0 as a visceral/nodal lesion injection followed by pembrolizumab.
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. Life expectancy equal to or greater than six months. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2. 4. Has measurable disease as defined by RECIST v1.1 5. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed advanced or metastatic Merkel cell carcinoma a. Must have at least one deep-seated visceral/nodal greater than 3 mm in its longest diameter 6. Subject should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab. 7. Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed. 8. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol. Exclusion Criteria 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements. 2. Subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids. 3. Subjects with recurrent resectable MCC 4. Subjects who have received prior systemic chemotherapy 5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study. 6. Active, known, or suspected autoimmune disease. Potential subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low grade autoimmune toxicity is NOT an exclusion under this criterion. 7. A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of IFx-Hu2.0 administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Contact & Investigator
Andrew S Brohl, MD
PRINCIPAL INVESTIGATOR
Collaborator
Frequently Asked Questions
Who can join the NCT06940440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Or Metastatic Merkel Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06940440 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06940440 currently recruiting?
Yes, NCT06940440 is actively recruiting participants. Contact the research team at jbianco@tuhurabio.com for enrollment information.
Where is the NCT06940440 trial being conducted?
This trial is being conducted at Tampa, United States, Madison, United States.
Who is sponsoring the NCT06940440 clinical trial?
NCT06940440 is sponsored by TuHURA Biosciences, Inc.. The principal investigator is Andrew S Brohl, MD at Collaborator. The trial plans to enroll 9 participants.