A Phase 1 Study of ELI-002 7P Immunotherapy in People with Digestive Cancers

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Full Title

First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS viral oncogene homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors

Purpose

The purpose of this study is to assess the safety of the investigational immunotherapy drug ELI-002 7P in people with pancreatic, colorectal, bile duct, or gallbladder cancers that have been surgically removed and contain mutations in the KRAS or NRAS genes. These mutations can cause cancer cells to grow. ELI-002 7P teaches the immune system to target these mutations and mount an anti-cancer response. It is considered a cancer vaccine and is given as an injection under the skin.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have pancreatic, colorectal, bile duct, or gallbladder cancer that has been surgically removed and was previously treated with chemotherapy or chemoradiation.
  • Patients’ tumors must contain KRAS or NRAS mutations.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of ELI-002 7P.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Eileen O’Reilly at 646-888-4182.

Protocol

22-352

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05726864