IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTuHURA Biosciences, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age.
Life expectancy equal to or greater than six months.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
Active disease measurable by CT or MRI, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded).
Disqualifiers
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.
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.
Subjects with recurrent resectable MCC
Subjects who have received prior systemic chemotherapy
Trial design
Design model
Single group
Treatments tested in this trial
IFx-Hu2.0
DrugTherapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
Pembrolizumab
DrugTherapeutic Classification: • Immunotherapy (Immune checkpointinhibitor) Route of administration: • Intravenous (IV) infusion
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: IFx-Hu2.0Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Safety
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.
Time frame
28 days from last dose of IFx-Hu2.02
Feasibility
Feasibility is defined as the ability to treat ≥50% of subjects (i.e. 5/9) in the per-protocol analysis.
Time frame
28 days from last dose of IFx-Hu2.0Sponsors and contacts
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Source ClinicalTrials.gov