drugset / Trial / NCT03394937

Safety of Intranodal ECI-006 in Melanoma Patients

NCT03394937 ↗

Phase 1 Terminated 21 enrolled eTheRNA immunotherapies
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped: “Expiry of study medication”

Drugs

EvaluationDrugModalityDoseRoute
Subject ECI-006 Messenger RNA (mRNA) 600 ug Other
Subject ECI-006 Messenger RNA (mRNA) 1800 ug Other
Subject ECI-006 Messenger RNA (mRNA) 3600 ug Other

Indications