Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

Phase 1TerminatedNCT03189030

Aduro Biotech, Inc.28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

pLADDBIOLOGICAL

via IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0

Time frame: Through study completion, an average of 12 months

Data from ClinicalTrials.gov

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