INO 5401 Vaccination in BRCA1/2 Mutation Carriers

NCT04367675 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 842686, UPCC 06019
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.

Conditions

BRCA1/2 Mutation

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities

  Dose-limiting toxicities will be classified by system organ class (SOC), preferred term (PT), severity, and relationship to Study Treatment.

  for 2 years after last dose of study treatment

Study Arms (2)

INO-5401

EXPERIMENTAL

Participants receive INO-5401 vaccine, followed by electroporation, on Day 1, Week 4, Week 8, and Week 12

Drug: INO-5401; Device: Cellectra 2000

INO-5401 and INO-9012

EXPERIMENTAL

Participants receive INO-5401 and INO-09012 vaccine, followed by electroporation, on Day 1, Week 4, Week 8, and Week 12

Drug: INO-5401; Drug: INO-9012; Device: Cellectra 2000

Interventions

INO-5401 DRUG

INO-5401 contains genes which are active in human cancers (hTERT, PMSA, and WNT1) and are felt to be good targets for the immune system both people who have had cancer or for those at increased risk of getting cancer.

INO-5401; INO-5401 and INO-9012

INO-9012 DRUG

INO-9012 contains the gene for IL12, a part of your body's immune system. It is possible that adding this to INO-5401 will increase the immune response to the vaccine.

INO-5401 and INO-9012

Cellectra 2000 DEVICE

The device will deliver a small electric charge through 5 needles to increase the amount of the study vaccine taken up by the muscle.

INO-5401; INO-5401 and INO-9012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated IRB approved informed consent.
• Females and males age 18+.
• Documented carrier of a pathogenic or likely pathogenic mutation in BRCA1 or BRCA2.
• Diagnosis of invasive breast cancer, invasive ovarian cancer, pancreatic cancer (apart from neuroendocrine) or prostate cancer with completion of adjuvant therapy and no clinical evidence of disease according to standard of care.
• Minimum of 2 clear sites on the skin to allow for injection.
• ECOG performance status of 0.
• Normal ECG or ECG without clinically significant findings and which does not require clinical action.
• Normal bone marrow, hepatic, and renal function.
• Females who are post-menopausal only.
• Male subjects with reproductive potential must be willing to use a condom with female partners of reproductive potential and their female sexual partners should use an additional highly effective method of birth control. This is required from screening through 24 weeks after the last dose of immunotherapy.
• Able and willing to comply with all study procedures.
• Signed and dated IRB approved informed consent.
• Females and males age 18+.
• Documented carrier of a pathogenic or likely pathogenic mutation in BRCA1 or BRCA2.
• With or without prior prophylactic (but not therapeutic) mastectomy or salpingo-oophorectomy.

You may not qualify if:

• Previous treatment with INO-5401 or IL-12 containing therapy, or any other DNA immunotherapy.
• Prior history of invasive cancer other than those listed above. History of localized superficial non-melanoma skin cancers, melanoma in situ, cervical intraepithelial neoplasia, or breast ductal carcinoma in situ is allowed.
• Pregnant or breast-feeding subjects.
• Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation; continued participation in an observational study is allowed.
• Cardiac pre-excitation syndromes.
• Prior major surgery within 4 weeks of first study treatment.
• Presence of acute or chronic bleeding or clotting disorder that would contraindicate intramuscular injections or use of blood thinners within 2 weeks of first study treatment.
• Any concurrent condition requiring the continued or anticipated use of systemic steroids or immunosuppressive therapy. All systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment.
• History of clinically significant disease or other immunosuppressive disease.
• HIV infection.
• Known history of hepatitis B and/or hepatitis C with active viral replication.
• Receipt of any blood product within 2 weeks before signing ICF.
• Administration of any vaccine, except influenza vaccine, within 4 weeks of the first study treatment. Administration of influenza vaccine within 2 weeks of first study treatment.
• Presence of metal implants or implantable medical device within 5 cm of the planned site of injection/EP including a cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the intended deltoid injection site, unless deemed acceptable by a cardiologist.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

Sponsors & Collaborators

• Inovio Pharmaceuticals: collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Vinayak S, Cecil DL, Disis ML. Vaccines for breast cancer prevention: Are we there yet? Mol Aspects Med. 2024 Aug;98:101292. doi: 10.1016/j.mam.2024.101292. Epub 2024 Jul 10. No abstract available.

  PMID: 38991631 DERIVED

MeSH Terms

Interventions

rocakinogene sifuplasmid

Study Officials

• Susan Domchek, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 20, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)