A Phase 2 Study of siG12D LODER in Combination with Chemotherapy in Patients with Locally Advanced Pancreatic Cancer

John Theurer Cancer Center at Hackensack Meridian Health Hackensack University Medical Center is 1 of 4 academic medical centers in the U.S. to participate in a cutting-edge Phase 2 multinational clinical trial of gene therapy for previously untreated, Inoperable pancreatic cancer.

The trial is a Prospective, Multinational, Multi-Center, Phase 2, Randomized, Controlled, Open-Label Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of siG12D-LODER in the Treatment of Patients with Unresectable Locally Advanced Pancreatic Cancer when used in Conjunction with Standard Chemotherapy (Gemcitabine+nab-Paclitaxel) versus Chemotherapy (Gemcitabine+nab-Paclitaxel) alone.

The purpose of this study is to assess the safety and effectiveness of a new medication called siG12D-LODER when given with standard chemotherapy (gemcitabine and nab-paclitaxel) as the first treatment for inoperable pancreatic cancer. siG12D-LODER is a small capsule, measuring about a quarter of an inch in length, which releases a drug called siG12D into the tumor over about three months. siG12D-LODER targets and kills tumor cells. The siG12D specifically targets KRAS mutations (genetic alterations), which are common in patients with pancreatic cancer.

siG12D-LODER is inserted directly into the tumor via endoscopy (a tube inserted down the esophagus into the stomach). Guided by endoscopic ultrasound, the doctor inserts siG12D-LODER into the tumor via a needle inserted through the stomach. Doctors insert a new siG12D-LODER capsule every three months until a change in the cancer is observed.

Patients in this study will be randomly assigned to receive siG12D-LODER plus standard chemotherapy, or standard chemotherapy alone (which is given by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have previously untreated inoperable (stage III) pancreatic cancer.

Patients who receive siG12D-LODER must have tumors that are accessible via endoscopy.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is for patients age 18 and older.

For more information, visit https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486054/#!po=50.0000

Other protocol defined inclusion/exclusion criteria could apply. If you are a physician and would like more details about this study, please contact us at

JTCC.Research@HackensackMeridian.org.

Investigators

Rosario Ligresti, MD, FASGE

Martin E Gutierrez, MD

Diseases

Hepatobiliary › Pancreatic Cancer

Upper Gastrointestinal › Pancreatic Cancer

Location

John Theurer Cancer Center, Hackensack University Medical Center

ABOUT JOHN THEURER CANCER CENTER AT HACKENSACK UNIVERSITY MEDICAL CENTER

John Theurer Cancer Center at Hackensack Meridian Health Hackensack University Medical Center is New Jersey’s largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 14 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. Housed within Hackensack University Medical Center, a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. For additional information, please visit www.jtcancercenter.org.

ABOUT HACKENSACK MERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 16 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children’s hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; 11 community hospitals - Ocean Medical Center in Brick, Riverview Medical Center in Red Bank, Mountainside Medical Center in Montclair, Palisades Medical Center in North Bergen, Raritan Bay Medical Center in Perth Amboy, Southern Ocean Medical Center in Manahawkin, Bayshore Medical Center in Holmdel, Raritan Bay Medical Center in Old Bridge, and Pascack Valley Medical Center in Westwood, JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 160 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, and urgent care and after-hours centers. Hackensack Meridian Health has 33,000 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network's notable distinctions include having one of only five major academic medical centers in the nation to receive Healthgrades America's 50 Best Hospitals Award for five or more consecutive years, four hospitals among the top 10 in New Jersey, including Hackensack University Medical Center which is ranked No. 1 by U.S. News and World Report. Other honors include consistently achieving Magnet® recognition for nursing excellence from the American Nurses Credentialing Center, recipient of the John M. Eisenberg Award for Patient Safety and Quality from The Joint Commission and the National Quality Forum, a six-time recipient of Fortune's "100 Best Companies to Work For," one of the "20 Best Workplaces in Health Care" in the nation, and the number one "Best Place to Work for Women." Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit www.HackensackMeridianHealth.org.