Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
NCT ID: NCT03189030
Last Updated: 2020-10-01
Study Results
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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TERMINATED
PHASE1
28 participants
INTERVENTIONAL
2017-05-02
2020-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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
pLADD
via IV infusion
Interventions
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pLADD
via IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* known allergy to both penicillin and sulfa drugs
* implanted devices that cannot be easily removed
* immunodeficiency, immune compromised state or receiving immunosuppressive therapy
18 Years
ALL
No
Sponsors
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Hanlee P. Ji, MD
UNKNOWN
Aduro Biotech, Inc.
INDUSTRY
Responsible Party
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Locations
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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, United States
Mary Crowley Cancer Research - Medical City
Dallas, Texas, United States
Countries
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Other Identifiers
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ADU-CL-12
Identifier Type: -
Identifier Source: org_study_id
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