Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04160065
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2019-11-07
Brief Title:
Immunotherapy With IFx-Hu20 Vaccine for Advanced Non-melanoma Skin Cancers
Sponsor:
TuHURA Biosciences Inc
Organization:
TuHURA Biosciences Inc
Study Overview
Official Title:
Phase 1 Trial of Intralesional Immunotherapy With IFx-Hu20 Vaccine in Patients With Advanced Non-melanoma Skin Cancers
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04853602
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
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 01 mg of IFx-Hu20 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 andor 42 7 days depending on the cohort exposure escalation and expansion design
Detailed Description:
Approximately twenty adult patients 18 years of age of any sex ethnicity and race with histologically confirmed advanced non-melanoma skin cancers with accessible lesions will be eligible for study enrollment and treatment with IFx-Hu20 ie 20 total patients across both indications These types of advanced non-melanoma skin cancers are very rare in the pediatric population 18 years of age with only scattered case reports The potential for development of this product for pediatric subjects with non-melanoma skin cancers will be evaluated after the results of this study are available
Patients must have at least one injectable lesion defined as an easily palpable superficial lesion cutaneous subcutaneous or lymph nodal metastasis that can be accurately localized stabilized by palpation and is superficial enough to enable intralesional injection
To be eligible for this study patients must have progressed despite standard therapyies or are intolerant to or refused standard therapyies
Enrollees will receive IFx-Hu20 as a monotherapy at up to three-time points Depending on the number of accessible lesions a patient could receive up to three doses across three lesions one dose per lesion The maximum number of lesions to be injected at any time point under this protocol is three lesions Blood will be collected from these patients prior to treatment administration at every drug administration visit These samples will be used to perform CBC and clinical chemistry tests A urine sample will be obtained for urinalysis for protein and blood at the same frequency Blood samples will also be drawn at the same intervals for immune response evaluation as well
This is primarily a safety study that is designed to evaluate IFx-Hu20 monotherapy and provide foundational evidence to potentially support further studies investigating IFx-Hu20 anti-PD-1 combination therapy for patients with non-melanoma skin cancers
Patients must have at least one injectable lesion defined as an easily palpable superficial lesion cutaneous subcutaneous or lymph nodal metastasis that can be accurately localized stabilized by palpation and is superficial enough to enable intralesional injection
To be eligible for this study patients must have progressed despite standard therapyies or are intolerant to or refused standard therapyies
Enrollees will receive IFx-Hu20 as a monotherapy at up to three-time points Depending on the number of accessible lesions a patient could receive up to three doses across three lesions one dose per lesion The maximum number of lesions to be injected at any time point under this protocol is three lesions Blood will be collected from these patients prior to treatment administration at every drug administration visit These samples will be used to perform CBC and clinical chemistry tests A urine sample will be obtained for urinalysis for protein and blood at the same frequency Blood samples will also be drawn at the same intervals for immune response evaluation as well
This is primarily a safety study that is designed to evaluate IFx-Hu20 monotherapy and provide foundational evidence to potentially support further studies investigating IFx-Hu20 anti-PD-1 combination therapy for patients with non-melanoma skin cancers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None