INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

NCT04398433 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: RRP-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 11

Brief Summary

This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in participants with human papilloma virus type 6 (HPV-6) and/or type 11 (HPV-11)-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) as defined by age at first diagnosis \<12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.

Conditions

Respiratory Papillomatosis

Keywords

Human papilloma virus (HPV)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

  An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or birth defect, or was considered an important medical event. TEAEs were defined for this trial as any AEs that occurred following Day 0 following administration of study drug (IM + EP), until 30 days following the last dose. TEAEs included both serious and non-serious TEAEs.

  From first dose of study drug through 30 days following the last dose (approximately up to Week 13)

Secondary Outcomes (6)

• Change in Number of Recurrent Respiratory Papillomatosis (RRP) Surgical Interventions in One Year Following Day 0, Compared to One Year Prior to Day 0

  Up to Week 52

• Percentage of Participants by Percent Reduction in RRP Surgical Interventions Post Baseline Compared to Prior Year

  Up to Week 52

• Change From Baseline in RRP Staging Assessment Scores Over Time

  Baseline, Weeks 6, 11, 26, and 52

• Change in Interferon-gamma Enzyme-Linked Immunosorbent Spot (IFN-γ ELISpot) Response Magnitude for IFN-γ Secreting Cells in Peripheral Blood Mononuclear Cells (PBMCs)

  Baseline, Weeks 6, 9, 11, 26, and 52

• Change in Flow Cytometry Response Magnitude for T-cell Phenotype and Lytic Potential in PBMCs

  Baseline, Weeks 6, 9, 11, 26, and 52

Other Outcomes (1)

• MicroRNA (miRNA) Expression Related to Reduced Frequency of RRP Surgical Intervention

  Baseline, Week 6

Study Arms (3)

INO-3107: Group 1

EXPERIMENTAL

Participants who had less than or equal to (≤) 2 surgeries received 6.25 milligrams per milliliter (mg/mL) INO-3107, intramuscular (IM) injection, followed by electroporation (EP) using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.

Drug: INO-3107; Device: CELLECTRA® 2000

INO-3107: Group 2

EXPERIMENTAL

Participants who had 3-5 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.

Drug: INO-3107; Device: CELLECTRA® 2000

INO-3107: Group 3

EXPERIMENTAL

Participants who had more than or equal to (≥) 6 surgeries received 6.25 mg/mL INO-3107, IM injection, followed by EP using CELLECTRA® 2000 at Day 0, Week 3, Week 6, and Week 9.

Drug: INO-3107; Device: CELLECTRA® 2000

Interventions

INO-3107 DRUG

INO-3107 administered by IM injection.

INO-3107: Group 1; INO-3107: Group 2; INO-3107: Group 3

CELLECTRA® 2000 DEVICE

CELLECTRA® 2000 device used for EP following IM delivery of INO-3107.

INO-3107: Group 1; INO-3107: Group 2; INO-3107: Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-documented HPV-6- or HPV-11-positive respiratory papilloma or documentation of low-risk positive HPV using a Sponsor approved HPV-6/11 type-specific assay
• Requirement for frequent RRP intervention to remove or resect respiratory papilloma, as defined as at least two RRP surgical (including laser) interventions in the year prior to and including Day 0
• Must be an appropriate candidate for upcoming surgical intervention as per Investigator judgment and RRP Staging Assessment score
• Adequate bone marrow, hepatic, and renal function
• Participants must meet one of the below requirements:
• Be of non-child bearing potential (≥12 months of non-therapy-induced amenorrhea, confirmed by follicle-stimulating hormone \[FSH\], if not on hormone replacement)
• Be surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females)
• Agree to use one highly effective or combined contraceptive methods that result in a failure rate of \<1% per year during the treatment period and at least through week 12 after last dose
• Agree to abstinence from penile-vaginal intercourse, when this is the participant's preferred and usual lifestyle

You may not qualify if:

• Recipient of therapy directed towards RRP disease (other than surgery or ablation) including but not limited to anti-virals (including cidofovir), radiation, chemotherapy, anti-angiogenic therapy (including bevacizumab), prophylactic HPV vaccination (including Gardasil) as therapeutic intervention, or therapy with an experimental agent within 3 months prior to Day 0
• Ongoing or recent (within 1 year) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments, with the exception of: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment
• Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, including systemic corticosteroids
• High risk of bleeding or require the use of anticoagulants for management of a known bleeding diathesis
• Recipient of any live virus vaccine within 4 weeks prior to the first dose of trial treatment or any non-live vaccine within two weeks prior to the first dose of trial treatment
• History of clinically significant, medically unstable disease which, in the judgment of the Investigator, would jeopardize the safety of the participant, interfere with trial assessment or evaluation, or otherwise impact the validity of the trial results
• Fewer than two acceptable sites are available for IM injection considering the deltoid and anterolateral quadriceps muscles. Study treatment should not be given within 2 centimeters (cm) of a tattoo, keloid or hypertrophic scar. If there is implanted metal, implanted device, within the same limb the use of the deltoid muscle on the same side of the body is excluded
• Prisoners or participants who are compulsory detained (involuntary incarceration) for treatment of either a psychiatric or physical (i.e. infectious disease) illness
• Any medical or psychological or non-medical condition that might interfere with the participation or safety of the participant, as determined by the investigator

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (11)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of California at Davis

Sacramento, California, 95817, United States

Location

Winship at Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

NYU Langone Voice Center

New York, New York, 10016, United States

Location

UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77005, United States

Location

Related Publications (1)

• Mau T, Amin MR, Belafsky PC, Best SR, Friedman AD, Klein AM, Lott DG, Paniello RC, Pransky SM, Saba NF, Howard T, Dallas M, Patel A, Morrow MP, Skolnik JM. Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11-Associated Recurrent Respiratory Papillomatosis. Laryngoscope. 2023 Nov;133(11):3087-3093. doi: 10.1002/lary.30749. Epub 2023 May 19.

  PMID: 37204106 DERIVED

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Results Point of Contact

• Title: Study Director
• Organization: Inovio Pharmaceuticals

clinical.trials@inovio.com

267-440-4237

Study Officials

• Jeffrey Skolnik, MD

  Inovio Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 21, 2020
• Study Start: October 7, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
• Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

Locations

US (11)