What is the Purpose of this Study?
The purpose of this study is to evaluate the safety of an investigational drug called ELI-002 7P and determine whether it works to treat pancreatic ductal adenocarcinoma or colorectal cancer. Study procedures include collection of blood for research analysis, lab work, demographics, questionnaires, patient diaries, physical exams, and imaging. The study is being conducted for patients with specific types of mutations (mKRAS- mutant kirsten rat sarcoma viral oncogene homolog) or mNRAS (mutant neuroblastoma rat viral oncogene homolog) present in their cancer. ELI-002 7P is a treatment that teaches the patient’s own immune system to fight cancer by training it to target the mutation found on cancer (either mKRAS or mNRAS). Participants in this study will have already undergone successful surgical resection.
Eligibility
- * KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor
- * Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
- * Screening CT is negative for recurrent disease
- * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi
More about this Clinical Trial
What is the full name of this clinical trial?
ELI-002-201: First in Human Phase 1/2 Trial of ELI-002 7P Immunotherapy as Treatment for Subjects with Kirsten Rat Sarcoma /Neuroblastoma RAS viral oncogene homolog Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors