NCT01147965

QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA

A Phase I/II Study of Active Immunotherapy With Ad5 [E1-,E2b-]-CEA(6D) Vaccine in Patients With Advanced or Metastatic Malignancies Expressing CEA

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: NantCell, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects (good and bad) that a cancer vaccine has on you and your cancer. The cancer vaccine is called Ad5 \[E1-, E2b-\]-CEA(6D)or ETBX-011 and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine can tell the immune system to attack cancer cells which make CEA. The investigators are trying to determine whether giving this virus is safe and whether this causes a strong immune system attack on the cancer. ETBX-011 is an investigational drug.

Detailed description

This is a phase I/II study with the primary purpose to determine the safety of immunization with Ad5 \[E1-, E2B-\]-CEA(6D), in patients with advanced or metastatic CEA-expressing malignancies. The secondary objectives are to evaluate CEA-specific immune responses to the immunizations and to obtain preliminary data on clinical response rate. The study population consists of patients with a histologically confirmed diagnosis of metastatic malignancy that is CEA positive who were previously treated with standard therapy known to have a possible survival benefit or refused such therapy. The study will determine the safety of three dosage levels of Ad5 \[E1-, E2B-\]-CEA(6D) vaccine (phase I component), and the maximally tolerated dose of Ad5 \[E1-, E2B-\]-CEA(6D) vaccine (phase II component). The study drug is Ad5 \[E1-, E2B-\]-CEA(6D) given by subcutaneous (SQ) injection every 3 weeks for 3 immunizations. We will evaluate safety in each cohort at least 3 weeks after the last patient in the previous cohort has received their first injection. A dosing scheme will be considered safe if \<33% of patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of 18 patients). We are currently enrolling up to 10 additional patients (Cohort 6) to evaluate safety, immunogenicity, and efficacy at the highest dose of vaccine.

Conditions

• Colorectal Cancer
• Lung Cancer
• Breast Cancer
• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ad5 CEA Vaccine	Ad5 \[E1-, E2b-\]-CEA(6D) Vector Vaccine

Timeline

• Start date: 2010-07-16
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2010-06-22
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study