We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03189030
Recruitment Status : Terminated (Study terminated due to business realignment)
First Posted : June 16, 2017
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Hanlee P. Ji, MD
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Biological: pLADD Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : September 2, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment arm
pLADD treatment cycle is once every 3 weeks; starting dose 1×10^8 colony-forming units (CFU) administered IV over 1 hour, and if tolerated increasing to 1×10^9 CFU
 Biological: pLADD
via IV infusion


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Through study completion, an average of 12 months ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189030


Locations
Layout table for location information
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
University of California Los Angeles
Los Angeles, California, United States, 90095
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Stanford
Stanford, California, United States, 94305
United States, Texas
Mary Crowley Cancer Research - Medical City
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Aduro Biotech, Inc.
Hanlee P. Ji, MD
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03189030    
Other Study ID Numbers: ADU-CL-12
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aduro Biotech, Inc.:
metastatic
microsatellite stable (MSS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases