Study of Personalized Immunotherapy 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.

• pLADD (Biological): via IV infusion

Primary outcomes

• 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

Sex: All, ages: 18 Years to any

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