Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

NCT ID: NCT03189030

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2020-09-02

Brief Summary

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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

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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

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Colorectal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

pLADD

Intervention Type BIOLOGICAL

via IV infusion

Interventions

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pLADD

via IV infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanlee P. Ji, MD

UNKNOWN

Sponsor Role collaborator

Aduro Biotech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Stanford

Stanford, California, United States

Site Status

Mary Crowley Cancer Research - Medical City

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ADU-CL-12

Identifier Type: -

Identifier Source: org_study_id

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