NCT04367675

INO 5401 Vaccination in BRCA1/2 Mutation Carriers

Phase 1b Study of INO-5401 Alone or INO-5401 in Combination With INO-9012 Followed by Electroporation in Adult Cancer and Non-Cancer Patients With BRCA1 or BRCA2 Mutations

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	INO-5401	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.
DRUG	INO-9012	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.
DEVICE	Cellectra 2000	The device will deliver a small electric charge through 5 needles to increase the amount of the study vaccine taken up by the muscle.

Timeline

• Start date: 2021-04-20
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2020-04-29
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study