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:

Terminated

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03189030

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
  • pLADD

Eligibility Criteria

        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
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:Terminated
Lead Sponsor:Aduro Biotech, Inc.

Trial Keywords

  • metastatic
  • microsatellite stable (MSS)

Last Updated

October 1, 2020