- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04160065
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers
Phase 1 Trial of Intralesional Immunotherapy With IFx-Hu2.0 Vaccine in Patients With Advanced Non-melanoma Skin Cancers
Study Overview
Status
Intervention / Treatment
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-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
Enrollment (Actual)
Phase
- Phase 1
Expanded Access
Contacts and Locations
Study Contact
- Name: James A Bianco, MD
- Phone Number: 104 (813) 875-6600
- Email: jbianco@morphogenesis-inc.com
Study Locations
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California
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Los Angeles, California, United States, 90033
- Usc Norris Comprehensive Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Life expectancy ≥ 3 months at recruitment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at the time of study treatment initiation.
- Males or females with histologically confirmed diagnosis of advanced non-melanoma skin cancers.
- Patients must have progressed despite standard therapy(ies) or are intolerant to or refused standard therapy(ies).
- Clinically measurable disease with at least 1 injectable lesion ≥ 3 mm in longest diameter; an injectable lesion is 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.
- No known bleeding diathesis or coagulopathy that would make intratumoral injection or biopsy unsafe
The entry laboratory criteria for subject eligibility must be less than or equal to Grade 1 adverse event levels for the parameters tested as defined by CTCAE v5.0:
Bone Marrow Function:
- Hemoglobin (Hb) > LLN 10 g/dL
- White Blood Cell Count (WBC) > LLN 3,000 cells/mcL
- Platelet count (PLT) > LLN - 75,000 /mcL
Blood Coagulation Parameters
- PT, INR < 1.5 x institutional ULN unless patient is therapeutically anticoagulated. If on anticoagulation PT/INR need to be within appropriate anticoagulation limits for the clinical indication. Patients who are receiving anticoagulants may participate in the trial if their anticoagulation can be stopped safely for several days at the time of biopsy.
Renal Function
- Serum Creatinine (SCr) < 1 - 1.5 x baseline; < 1 1.5 x ULN
Hepatic Function:
- Blood bilirubin < 1 - 1.5 x ULN if baseline was normal; < 1 1.5 x baseline if baseline was abnormal
- Serum Alanine Aminotransferase (ALT) < 1 - 3 x ULN if baseline was normal; 1.5 3 x baseline if baseline was abnormal
- Serum Aspartate Aminotransferase (AST) < 1 - 3 x ULN if baseline was normal; 1.5 3 x baseline if baseline was abnormal
- Alkaline Phosphatase (ALP) < 1 - 2.5 x ULN if baseline was normal; 2 2.5 x baseline if baseline was abnormal
- Gamma Glutylamyltransferase (GGT) < 1 - 2.5 x ULN, if baseline was normal; 2 2.5 x baseline if baseline was abnormal
- Males and females of reproductive potential must agree to continuously use adequate contraception prior to study entry and for up to 6 months thereafter. A female is of childbearing potential unless she has had a surgical procedure that would accomplish sterility such a bilateral tubal ligation, hysterectomy or has not had menses for the past 12 months.
- Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment
- Patient or legal representative must understand and sign a written informed consent form.
Exclusion Criteria:
- Concurrent use of any other investigational product or participation in another trial within 28 days before start of study treatment.
- Have received oncologic therapy within 2 weeks of planned IFx-Hu2.0 injection
- Presence or history of central nervous system metastasis [treated/stable brain metastasis are allowable when patients have received prior therapy for their brain metastases and their central nervous system (CNS) disease is radiographically stable (> 4 weeks)]
- Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study
- Concurrent steroid therapy (> 10 mg of daily prednisone equivalent) or other immunosuppressive therapies such as those needed for solid organ transplants and rheumatoid arthritis. Topical or inhaled steroids are allowable.
- History of organ allograft transplantation
- History of hemolytic anemia
- History of significant tumor bleeding, or coagulation or bleeding disorders.
- Patients with autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment. Prior autoimmune toxicity resolved to Grade 1 or less no longer requiring immunosuppressive therapy is not an exclusion under this criterion.
- Major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery
- Leptomeningeal involvement regardless of treatment status
- Active, clinically serious uncontrolled medical conditions such as HIV, HBV, HCV, and EBV infection
- 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
- Unwilling or unable to follow protocol requirements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion/time point
Exposure Escalation:
Cohort Expansion:
|
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. Therapeutic Classification:
Route of Administration:
Mechanism of Action:
Physiological Effect:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Grade 3-5, Treatment-Related Adverse Events per CTCAE 5.0
Time Frame: 28 days from last injection
|
28 days from last injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Enrolled Subjects who have completed the Trial without Major Protocol Deviations
Time Frame: 28 days from last injection
|
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
|
28 days from last injection
|
Best Overall Response per RECIST v1.1
Time Frame: 28 days from last injection
|
28 days from last injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew S Brohl, MD, Collaborator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- DNA Virus Infections
- Tumor Virus Infections
- Neuroendocrine Tumors
- Polyomavirus Infections
- Carcinoma, Neuroendocrine
- Carcinoma
- Skin Neoplasms
- Carcinoma, Merkel Cell
Other Study ID Numbers
- NMSC 2019-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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