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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

Clinical Trial Details

This clinical trial is for adult participants who have pancreatic ductal adenocarcinoma or colorectal cancer with a specific type of mutation (mKRAS or mNRAS) present in their cancer. 

The purpose of this study is to test the safety of an investigational treatment called ELI-002 7P, to confirm the safe dose and to determine if ELI-002 7P works in treating pancreatic ductal adenocarcinoma or colorectal cancer. ELI-002 7P is considered investigational and it is not approved by the United States Food and Drug Administration (U.S. FDA) for use outside of clinical studies.

ELI-002 7P is a treatment that teaches the immune system to fight cancer by training it to target the mutation found on participants' cancer. The treatment phase is made up of an Immunization Period, followed by a 2-month Observation Period and then a Booster Period.
   
The Immunization Period will occur over approximately 8 weeks in which ELI-002 7P will be given once a week for 4 weeks and then once every two weeks for a month. The Observation Period will occur over 2 months in which participants will have visits once a month but will not receive ELI-002 7P treatment. The Booster Period will occur over 1 month, in which participants will have visits once a week for 4 weeks and will be given ELI-002 7P at each visit.
   
After the treatment phase, participants will enter the follow-up phase, which will last up to 30 months from the end of the Booster Period. 
   
Some participants will be randomized (meaning they will be assigned by chance) into an observation group that will not receive ELI-002 7P treatment. Participants assigned to the observation group will have the opportunity to be treated with ELI-002 7P once their study doctor determines that their cancer has progressed.
   
This study will involve physical examinations, electrocardiograms (ECG), computed tomography (CT) or magnetic resonance imaging (MRI) scans, blood collection, completion of questionnaires and a study diary. Participants will also have a procedure called leukapheresis to collect the white blood cells from their blood. In total, participation will involve about 26 visits to the study site.
   
Overall participation in this study is expected to last approximately 35 months but may be longer for those assigned to the observation group who begin to receive ELI-002 7P once their cancer progresses.

Key Eligibility: 
  1. Adult with histologically or cytologically confirmed diagnosis of solid tumor (pancreatic ductal adenocarcinoma [PDAC] or colorectal cancer [CRC])
  2. Laboratory value that demonstrates at least 1 of the 7 mKRAS/NRAS alleles (eg, G12D, G12V, G12S, G12A, G12C, G12R or G13D) targeted by ELI-002 7P
  3. Prior treatment with a SOC chemotherapy or chemotherapy/chemoradiation (for PDAC participants)
  4. Prior treatment with standard of care chemotherapy (for CRC participants)

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2211025353

ClinicalTrials.gov:

NCT05726864

Sponsor:

ELI-002-201

Status

Not Yet Recruiting

Age Group

Adult

Sponsor