Phase 1A: ELI-002 7P (Low Peptide dose) for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope, Duarte, CAColorectal Cancer+14 MoreELI-002 7P - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial tests a new cancer therapy to see if it's safe & effective in treating solid tumors with mutated KRAS/NRAS. It builds on experience from a related product.

Eligible Conditions
  • Pancreatic Cancer
  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • KRAS G12D Mutation
  • KRAS G12R Mutation
  • KRAS G12V Mutation
  • KRAS G12A Mutation
  • KRAS G12C Mutation
  • KRAS G12S Mutation
  • KRAS G13D Mutation
  • Neurofibromatosis Type 1 with a G12D Mutation
  • Neurofibromatosis Type 1 with a G12R Mutation
  • Neurofibromatosis Type 1 (NF1)
  • Neuroblastoma RAS Viral Oncogene Homolog G12C Mutation

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Phage Therapy
1
OsrhAAT 1 mg/kg IV
1
S-217622: Group C

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 1 year

1 year
Phase 2: Determine the 1-year RFS
Day 28
Phase 1: Evaluate the safety of ELI-002 7P
Day 30
Phase 2: Evaluate the safety of ELI-002 7P
6 months
Phase 1 and Phase 2: Determine the biomarker reduction or clearance rate
Week 24
Phase 2: Determine the objective response rate (ORR) in subjects who crossover from Observation to ELI-002 7P treatment after confirmed progressive disease according to iRECIST
Week 106
Phase 2: Determine whether ELI-002 7P improves relapse-free survival (RFS) compared with Observation

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Phage Therapy
1
OsrhAAT 1 mg/kg IV
1
S-217622: Group C

Trial Design

4 Treatment Groups

Phase 1A: ELI-002 7P (Low Peptide dose)
1 of 4
Phase 1A: ELI-002 7P (High Peptide dose)
1 of 4
Phase 1B: ELI-002 7P
1 of 4
Phase 2 randomized: ELI-002 7P
1 of 4

Experimental Treatment

156 Total Participants · 4 Treatment Groups

Primary Treatment: Phase 1A: ELI-002 7P (Low Peptide dose) · No Placebo Group · Phase 1 & 2

Phase 1A: ELI-002 7P (Low Peptide dose)
Drug
Experimental Group · 1 Intervention: ELI-002 7P · Intervention Types: Drug
Phase 1A: ELI-002 7P (High Peptide dose)
Drug
Experimental Group · 1 Intervention: ELI-002 7P · Intervention Types: Drug
Phase 1B: ELI-002 7P
Drug
Experimental Group · 1 Intervention: ELI-002 7P · Intervention Types: Drug
Phase 2 randomized: ELI-002 7P
Drug
Experimental Group · 1 Intervention: ELI-002 7P · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Elicio TherapeuticsLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

How many volunteers have joined this investigation?

"To execute this research, Elicio Therapeutics requires 156 eligible patients to be recruited from multiple sites including Northwell Health in Lake Success and Memorial Sloan Kettering Cancer Center. Both of these locations are situated within New York State." - Anonymous Online Contributor

Unverified Answer

Are there any open positions in this trial?

"Affirmative. According to clinicaltrials.gov, this scientific trial has resumed recruitment and is seeking 156 people from 4 distinct medical facilities. This research project was first posted on March 1st 2023 with a recent update being applied on the 7th of that same month." - Anonymous Online Contributor

Unverified Answer

Are there a copious amount of medical centers conducting the trial in North America?

"Currently, there are 4 sites that have opened recruitment for this trial. These include Lake Success in New York and Houston along with two other medical centres. We advise those interested to select the closest centre available so as to reduce the burden of travelling long distances if they decide to take part." - Anonymous Online Contributor

Unverified Answer

What kind of results is this investigation intended to yield?

"As stated by the study sponsor, Elicio Therapeutics, the primary outcome that will be tracked over a 28 day period post first dose of ELI-002 7P is relapse-free survival (RFS) in comparison to Observation. Additionally, safety metrics such as Adverse Events and clinically significant laboratory tests/vital signs will also be monitored. Furthermore, objective response rate (ORR) for those who cross from Observation to ELI-002 7P treatment after confirmed progression and biomarker clearance or reduction are other objectives this trial aims to measure." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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