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Safety of Intranodal ECI-006 in Melanoma Patients

NCT03394937 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-06-21

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of cancer immunotherapy ECI-006 and to determine its ability to induce a measurable immune response against the tumor associated antigens.

In Cohort 1, ECI-006 will be administered 5 times by intranodal injection in melanoma patients after resection of their tumor.

In Cohort 2, ECI-006 will be administered 9 times by intranodal injection on top of standard of care anti PD1 in metastatic melanoma patients with stable disease after 3 to 12 months treatment.

ECI-006 activates key immunologically active cells to direct the immune system against the cancer. Expected potential risks for ECI-006 are non-serious and related to the local administration of the product. Hence, the therapy suggested here has the promise to offer considerable benefit to patients without any major risk.

Conditions

Interventions

BIOLOGICAL

ECI-006

ECI-006 consists of TriMix and 5 tumor associated antigens mRNA. TriMix is a mixture of mRNAs that encodes potent immune stimulating molecules

Sponsors & Collaborators

  • eTheRNA immunotherapies

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2020-12-31
Completion
2021-01-29

Countries

  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03394937 on ClinicalTrials.gov