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ELI-002 Immunotherapy for Pancreatic Cancer (AMPLIFY-201 Trial)
AMPLIFY-201 Trial Summary
This trial is testing a new immunotherapy to see if it is safe and effective in treating patients with solid tumors who have a KRAS or NRAS mutation.
AMPLIFY-201 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowAMPLIFY-201 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AMPLIFY-201 Trial Design
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Who is running the clinical trial?
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- A CT scan does not show signs of the disease coming back.My blood tests show cancer markers despite having had surgery and/or chemotherapy/radiation.My tumor has a KRAS or NRAS mutation.I am currently taking drugs that suppress my immune system.I have cancer that has spread to my brain.My tumor has a mutation for which there is an approved treatment, and I can receive this treatment.I am fully active or can carry out light work.
- Group 1: ELI-002 2P Cohort 2
- Group 2: ELI-002 2P Cohort 3
- Group 3: ELI-002 2P Cohort 4
- Group 4: ELI-002 2P Cohort 5
- Group 5: ELI-002 2P Cohort 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What objectives is this clinical experiment seeking to accomplish?
"This study's primary goal, which will be monitored over a month following the final dosage, is to ascertain the MTD of ELI-002 and its RP2D. Additionally, researchers shall assess ctDNA clearance rates between treatment groups, overall survival times from randomization till death for each group, and 1-year RFS probability among both cohorts."
Is there still capacity for enrolment into this trial?
"Affirmative. According to the clinicaltrials.gov record, this research is still recruiting subjects and was initially posted on October 4th 2021 with a recent update from November 21st 2022. This endeavor needs 18 contributors across 8 distinct sites."
Has the ELI-002 2P drug obtained sanction from the FDA?
"Our evaluation at Power put ELI-002 2P's safety level at 1, considering it is only in its initial testing phase with limited evidence of efficacy and security."
To what extent is the general population participating in this research endeavor?
"A total of 18 eligible patients are required to successfully run the trial, which is administrated by Elicio Therapeutics from multiple locations. These include Massachusetts General Hospital in Boston and University of Colorado in Aurora."
How many research centers are overseeing this investigation?
"This clinical trial has sites located in Boston, Aurora and Houston as well as 8 additional locations. Specifically, Massachusetts General Hospital, University of Colorado and The University of Texas MD Anderson Cancer Center are all recruiting participants for this study."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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