Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03189030

Enrollment

Registered

2017-06-16

Start date

2017-05-02

Completion date

2020-09-02

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

metastatic, microsatellite stable (MSS)

Brief summary

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.

Interventions

BIOLOGICALpLADD

via IV infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026