Study Stopped
Study terminated due to business realignment
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
1 other identifier
interventional
28
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2017
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedFirst Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2020
CompletedOctober 1, 2020
September 1, 2020
2.5 years
June 14, 2017
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
Through study completion, an average of 12 months
Study Arms (1)
Treatment arm
EXPERIMENTALpLADD 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aduro Biotech, Inc.lead
- Hanlee P. Ji, MDcollaborator
Study Sites (5)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Stanford
Stanford, California, 94305, United States
Mary Crowley Cancer Research - Medical City
Dallas, Texas, 75230, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 16, 2017
Study Start
May 2, 2017
Primary Completion
October 15, 2019
Study Completion
September 2, 2020
Last Updated
October 1, 2020
Record last verified: 2020-09