NCT03189030

Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Aduro Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.

Detailed description

This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	pLADD	via IV infusion

Timeline

• Start date: 2017-05-02
• Primary completion: 2019-10-15
• Completion: 2020-09-02
• First posted: 2017-06-16
• Last updated: 2020-10-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study