Clinical Trials /

Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

NCT03189030

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: ADU-CL-12
  • NCT ID: NCT03189030

Conditions

  • Colorectal Neoplasms

Interventions

DrugSynonymsArms
pLADDTreatment arm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment armExperimentalpLADD 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

    Eligibility Criteria

            Inclusion Criteria:
    
              -  metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
    
              -  radiographically stable, measurable disease at Screening
    
              -  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
    
              -  enrollment in another therapeutic protocol after completion of frontline therapy
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
    Time Frame:Through study completion, an average of 12 months
    Safety Issue:
    Description:Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Aduro Biotech, Inc.

    Trial Keywords

    • metastatic
    • microsatellite stable (MSS)

    Last Updated

    June 15, 2017