ELI-002 2P for Minimal Residual Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Minimal Residual Disease+17 More
ELI-002 2P - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a new type of immunotherapy may help treat patients with cancer.

See full description

Eligible Conditions

  • Minimal Residual Disease
  • KRAS G12R
  • NRAS G12D
  • NRAS G12R
  • Ovarian Cancer
  • Bile Duct Carcinoma
  • KRAS G12D
  • Colorectal Carcinoma (CRC)
  • Non-small Cell Lung Cancer
  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
  • Cholangiocarcinoma
  • Carcinoma of Gallbladder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Minimal Residual Disease

Study Objectives

This trial is evaluating whether ELI-002 2P will improve 5 primary outcomes and 7 secondary outcomes in patients with Minimal Residual Disease. Measurement will happen over the course of 30 days after the last ELI-002 dose.

1 year
Phase 2: Determine the 1-year RFS
24 months
Phase 2: Determine the overall survival (OS)
Day 28
Determine the MTD of ELI-002 and the RP2D
Phase 1A: Determine the MTD of ELI-002 and the RP2D
Day 30
Evaluate the safety of ELI-002
Phase 1: Evaluate the safety of ELI-002
Day 30
Phase 2: Evaluate the safety of ELI-002
6 months
Determine the circulating tumor DNA (ctDNA) reduction and clearance rate
Phase 1: Determine the ctDNA clearance rate
Phase 2: Determine the ctDNA clearance
Day 217
Phase 2: Determine the objective response rate (ORR) in subjects who crossover from Observation to ELI-002 after confirmed relapse
Day 791
Phase 2: Determine whether ELI-002 improves relapse-free survival (RFS) compared with Observation

Trial Safety

Safety Progress

1 of 3

Other trials for Minimal Residual Disease

Trial Design

3 Treatment Groups

ELI-002 2P Cohort 2
1 of 3
ELI-002 2P Cohort 1
1 of 3
ELI-002 2P Cohort 3
1 of 3
Experimental Treatment

This trial requires 18 total participants across 3 different treatment groups

This trial involves 3 different treatments. ELI-002 2P is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

ELI-002 2P Cohort 2
Drug
ELI-002 2P Amph-CpG-7909 (0.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
ELI-002 2P Cohort 1
Drug
ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
ELI-002 2P Cohort 3
Drug
ELI-002 2P Amph-CpG-7909 (2.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Minimal Residual Disease or one of the other 17 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
KRAS/NRAS mutated (G12D or G12R) solid tumor Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker 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

Patient Q&A Section

Can residual tumor be cured?

"Residual tumor is less likely to remain inactive than to remain active. However, depending on the stage in which it is discovered, residual tumor can be cured. At the highest stage, residual tumor is cured at a rate of 66%." - Anonymous Online Contributor

Unverified Answer

What causes residual tumor?

"Residual tumor is a significant problem in breast cancer and colorectal cancer. Most residual tumors are benign, but the rate of malignancy in residual tumor is very high." - Anonymous Online Contributor

Unverified Answer

What are common treatments for residual tumor?

"Patients treated with radiotherapy have a lower relapse rate than patients treated with chemotherapy alone. The use of radiotherapy for residual tumor may be justified." - Anonymous Online Contributor

Unverified Answer

How quickly does residual tumor spread?

"Findings from a recent study shows that residual tumor persists very fast; 20 to 30 weeks after surgery the residual tumors have completely disappeared. In many cases only small residual residuals can be identified." - Anonymous Online Contributor

Unverified Answer

What is residual tumor?

"Residual tumor is the residual of a primary tumor following a curative treatment such as surgery of a benign tumor. The primary tumor can either regress or persist after the treatment for the benign tumors." - Anonymous Online Contributor

Unverified Answer

What are the signs of residual tumor?

"Residual tumor, the size of the lung cancer is the strongest independent predictor of an increase in the development of new metastases or distant metastases." - Anonymous Online Contributor

Unverified Answer

How many people get residual tumor a year in the United States?

"Between 2005 and 2010, the incidence of residual tumor was decreasing. At any given time, most adult women undergoing surgery for ER+ breast cancer should expect to have residual tumor and approximately 15-20% of women will have substantial residual tumor following surgery for ER- breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for residual tumor?

"The survival rate of residual tumor is high for primary site. There were no differences according to the site of origin, but higher tumor stage and node metastasis were associated with death by residual tumor." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets residual tumor?

"In the elderly with a residual tumor on FDG PET/CT, the time to a second evaluation of the tumor increases as the mean age increases. There is no evidence that younger patients with a residual tumor do better than older patients in having a second evaluation. Younger patients who have a (new or) residual tumor may be treated with a watch-and-wait strategy (wait for 1–2 months). However, some patients should get a second evaluation because there is increased risk of tumor progress or new residual nodule(s) that should be examined." - Anonymous Online Contributor

Unverified Answer

Is eli-002 2p safe for people?

"Findings from a recent study found no significant changes in adverse events or serious side effects compared with placebo in people with unresectable hepatocellular carcinoma (HCC) treated with eli-002 2p as maintenance therapy following primary liver transplantation." - Anonymous Online Contributor

Unverified Answer

Does residual tumor run in families?

"Although there is strong evidence that in multiple families with an ascertained history of nonmetastatic solid tumors that a tumor is caused by a hereditary component, a significant proportion of such families lacked an accompanying history of a nonmetastatic solid cancer. Genetic counseling may be helpful to families when a solid tumor is present at time of diagnosis, and when there is an associated solid or hematologic cancer." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing residual tumor?

"Residual tumor, even in cases with very low incidence or risk factors, can arise. It is recommended to treat residual tumor even if there are no risk factors." - 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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