Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

Aduro Biotech

Status and phase: Terminated; Phase 1

Conditions: Colorectal Neoplasms

Treatments: Biological: pLADD

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03189030

ADU-CL-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Treatment arm

Experimental group

Description:

pLADD 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

Treatment:

Biological: pLADD