Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03189030
• Other study ID #: ADU-CL-12
• Status: Terminated
• Phase: Phase 1
• Start date: May 2, 2017
• Est. completion date: September 2, 2020

Study information

• Verified date: September 2020
• Source: Aduro Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: September 2, 2020
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)

• able to provide adequate tumor tissue from at least 1 accessible tumor site

• completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening

• on maintenance standard-of-care chemotherapies or on treatment holiday

• Eastern Cooperative Oncology Group (ECOG) 0 or 1

• adequate organ function

• progression of disease at the time of Enrollment

Exclusion Criteria:

• BRAF V600E mutation

• known allergy to both penicillin and sulfa drugs

• implanted devices that cannot be easily removed

• immunodeficiency, immune compromised state or receiving immunosuppressive therapy

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Biological:
• pLADD
via IV infusion

Locations

Country	Name	City	State
United States	Mary Crowley Cancer Research - Medical City	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Stanford	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Aduro Biotech, Inc.	Hanlee P. Ji, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0	Through study completion, an average of 12 months