Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines

Summary

Background: Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want to develop vaccines to teach the immune system to target and kill cancer cells. They want to test three of these vaccines (ETBX-071, ETBX-061, and ETBX-051) against mCRPC. Objective: To test the safety of combination ETBX-071, ETBX-061, and ETBX-051 and to study their effects on the immune system. Eligibility: People ages 18 and older with mCRPC that has not responded to standard therapies Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Computed tomography (CT) or magnetic resonance imaging (MRI) scans Bone scan Participants will get the vaccines as shots under the skin every 3 weeks for 3 doses. They may then have the shots every 8 weeks for up to 1 year. Participants will keep a diary to record any symptoms from the vaccines. Participants will have blood tests each time they get the vaccines. They will also have scans and other tests to measure the effect the vaccines have on their tumors. Participants will have a visit within 28 days after their last treatment. This includes a physical exam and blood and urine tests. Participants will then be contacted by phone every 3 months for the first year, every 6 months for the next 2 years, and every 12 months for another 2 years. Participants will be asked to join a long-term follow up study.

Timeline

Start

2018-07-24

Primary completion

2020-01-15

Completion

2021-03-09

Publications

• Bilusic M, McMahon S, Madan RA, Karzai F, Tsai YT, Donahue RN, Palena C, Jochems C, Marte JL, Floudas C, Strauss J, Redman J, Abdul Sater H, Rabizadeh S, Soon-Shiong P, Schlom J, Gulley JL. Phase I study of a multitargeted recombinant Ad5 PSA/MUC-1/brachyury-based immunotherapy vaccine in patients with metastatic castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2021 Mar;9(3):e002374. doi: 10.1136/jitc-2021-002374.

Drugs

Indications