Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers
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|ClinicalTrials.gov Identifier: NCT04160065|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : April 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma Cutaneous Squamous Cell Carcinoma Non-Melanoma Skin Cancers||Biological: IFx-Hu2.0||Phase 1|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
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-Hu2.0 (i.e. 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 therapy(ies), or are intolerant to or refused standard therapy(ies).
Enrollees will receive IFx-Hu2.0 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-Hu2.0 monotherapy and provide foundational evidence to potentially support further studies investigating IFx-Hu2.0 + anti-PD-1 combination therapy for patients with non-melanoma skin cancers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Intralesional Immunotherapy With IFx-Hu2.0 Vaccine in Patients With Advanced Non-melanoma Skin Cancers|
|Actual Study Start Date :||March 3, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion/time point
The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.
Route of Administration:
Mechanism of Action:
Other Name: pAc/emm55
- Number of Grade 3-5, Treatment-Related Adverse Events per CTCAE 5.0 [ Time Frame: 28 days from last injection ]
- Number of Enrolled Subjects who have completed the Trial without Major Protocol Deviations [ Time Frame: 28 days from last injection ]
- Objective Response Rate (ORR) per 2018 FDA Guidance on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics [ Time Frame: 28 days from last injection ]
- Best Overall Response per RECIST v1.1 [ Time Frame: 28 days from last injection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160065
|Contact: James A Bianco, MD||(813) 875-6600 ext firstname.lastname@example.org|
|United States, California|
|USC Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Jacob S Thomas, MD 323-865-0451 email@example.com|
|Contact: Rabia Rehman 323-865-0460 firstname.lastname@example.org|
|Principal Investigator: Jacob S Thomas, MD|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Andrew S Brohl, MD 813-745-4673 email@example.com|
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|Principal Investigator: Andrew S Brohl, MD|
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|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Ann W Silk, MD 617-632-3000 email@example.com|
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|Principal Investigator: Ann W Silk, MD|
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|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: John R Hyngstrom, MD 801-587-7000 email@example.com|
|Contact: Susan Sharry 801-585-3453 firstname.lastname@example.org|
|Principal Investigator: John R Hyngstrom, MD|
|Principal Investigator:||Andrew S Brohl, MD||Collaborator|