A Phase IA Study of ELI-002 Immunotherapy to Treat RAS-Mutated Pancreatic Cancer and Other Solid Tumors

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Full Title

First in Human Phase 1/2 Trial of ELI-002 Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors

Purpose

The purpose of this study is to find the best dose of ELI-002 that can be given in patients with pancreatic cancer and other solid tumors that contain mutations in a RAS gene (mKRAS or mNRAS mutations). ELI-002, given as a vaccine, “teaches” the immune system to target the mutations in patients’ cancers. ELI-002 is given as a subcutaneous (under the skin) injection.

Eligibility

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

  • Patients in this study must have pancreatic adenocarcinoma, colorectal cancer, bile duct cancer (cholangiocarcinoma), or gallbladder cancer that contains an mKRAS or mNRAS mutation.
  • Patients must have minimal residual disease, as measured by the detection of circulating tumor DNA in the blood 3 or more weeks after surgery or completion of chemotherapy.
  • At least 4 weeks must pass since the completion of prior therapy, and patients must have recovered without any ongoing complications or issues.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

Protocol

21-112

Phase

I/II

Investigator

Co-Investigators