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Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pLADD
Sponsored by
Aduro Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring metastatic, microsatellite stable (MSS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Medical Center
  • University of California Los Angeles
  • University of California Davis Comprehensive Cancer Center
  • Stanford
  • Mary Crowley Cancer Research - Medical City

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0

Secondary Outcome Measures

Full Information

First Posted
June 14, 2017
Last Updated
September 29, 2020
Sponsor
Aduro Biotech, Inc.
Collaborators
Hanlee P. Ji, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03189030
Brief Title
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to business realignment
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
September 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aduro Biotech, Inc.
Collaborators
Hanlee P. Ji, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
metastatic, microsatellite stable (MSS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
pLADD
Intervention Description
via IV infusion
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
Time Frame
Through study completion, an average of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Mary Crowley Cancer Research - Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

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