Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
- Conditions
- Colorectal Neoplasms
- Registration Number
- NCT03189030
- Lead Sponsor
- Aduro Biotech, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Through study completion, an average of 12 months Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
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
City of Hope National Medical Center🇺🇸Duarte, California, United States