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A Phase I, First-In-Human, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Clinical Trial Details

The goal of this clinical research study is to assess the safety, tolerability, immune response, and preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine (GAd20-209-FSP prime, and MVA-209-FSP boost) and pembrolizumab.

Nous-209 is an investigational study drug vaccination made up of 2 components, the prime (first) vaccine and the booster vaccine. “Investigational” means that the study drug is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). This means it has not been approved by the FDA as a treatment for cancer.

This is also an open-label, Phase 1 “First-in-Human” study which means this is the first time that people have received this drug (Nous-209). Open-label means that both the researchers and study participants know which treatments are being given.

The study is divided into two parts:
• Cohort A is dose escalation (low/high dose);
• Cohort B is dose expansion (dose identified from Cohort A).

This study is composed of a main study lasting 26 weeks, and an extended follow-up from week 27 to week 106 and further 4 weeks following the end of treatment for safety follow-up until week 110. The main study is composed of two groups known as cohorts. Cohort A first enrolls subjects to a low-dose vaccine and, if the safety parameters are met, additional subjects are enrolled to the high-dose vaccine. Cohort A will be comprised of 9-18 subjects. Cohort B, the expansion cohort, will be comprised of 12-16 subjects to be treated at the dose identified based on the safety information from Cohort A. Each subject will first undergo a series of screening tests to help the study doctor determine if they are eligible to participate.

Key Eligibility: 

Open to men and women above the age of 18 who have previously proven microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status (confirmatory testing is not required).

Participants with unresectable or metastatic, microsatellite instability high (MSI-H) or mismatch repair deficient CRC, gastric or G-E junction tumors who have progressed following prior treatment (2nd or further line of treatment) or participants with unresectable or metastatic, microsatellite instability high (MSI-H) or mismatch repair deficient CRC, gastric or G-E junction tumors who must have refused, or have been considered ineligible for chemotherapy; or for whom a clinical trial of an investigational agent plus pembrolizumab is considered appropriate by the investigator (1st line of treatment) are also eligible.

Participants with a history of active or suspected autoimmune disease, including ulcerative colitis and Crohn’s Disease, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g. Wegener’s Granulomatosis]) or CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis) or autoimmune thyroiditis are not eligible.

Participants with minor well controlled hypothyroidism may be eligible.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1908020684

ClinicalTrials.gov:

NCT04041310

Sponsor:

NOUS-209-01-00

Status

Open to Enrollment

Age Group

Adult

Sponsor