Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult

In brief

Ref: Protocol Version 9.1 05 December 2024. NOUS-209-01 is a multicenter, open-label, multiple cohorts, clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of Nous-209 genetic polyvalent vaccine plus pembrolizumab combination therapy in adult subjects with unresectable or metastatic deficient mismatch repair (dMMR) or MSI-H CRC, gastric, or gastro-esophageal junction (G-E junction) tumors. Nous-209 is based on a heterologous prime/boost regimen composed of the Great Ape Adenovirus GAd20-209-FSP used for priming and Modified Vaccinia virus Ankara MVA-209-FSP used for boosting. The Phase I portion of the study is a first-in-human (FIH) clinical study with a primary objective to elucidate the safety and tolerability of Nous-209 in addition to establishing the recommended Phase 2 dose (RP2D), whereas the Phase II was introduced to assess efficacy as the primary objective.

Key facts

Study ID

NCT04041310

Run by

Nouscom SRL

People needed

115

Starts

2019-10-21

Expected to finish

2026-10-30

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• City of Hope Comprehensive Cancer Center — Irvine, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• USC Norris Comprehensive Cancer Center — Newport Beach, California, United States
• Mt. Sinai — Miami Beach, Florida, United States
• Boca Raton Clinical Research — Plantation, Florida, United States
• Goshen Center for Cancer Care — Goshen, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Washington University School of Medicine, Division of Oncology — St Louis, Missouri, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Weill Cornell Medicine / New York-Presbyterian Hospital — New York, New York, United States
• MD Anderson Cancer Center (MDACC) — Houston, Texas, United States
• Cliniques Universitaires Saint-Luc - Centre du Cancer — Brussels, Belgium
• Centre Hospitalier de l'Ardenne - Libramont - Clinique du Sein — Libramont, Belgium
• CHU de Liège — Liège, Belgium
• Mount Sinai Hospital — Toronto, Canada
• Princess Margaret Cancer Center — Toronto, Canada
• Aorn Sg Moscati — Avellino, Italy
• Candiolo cancer Center,FPO IRCCS — Candiolo, Italy
• IRCCS Ospedale San Raffaele — Milan, Italy
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
• Ospedale Niguarda — Milan, Italy
• AOUS Policlinico Le Scotte — Siena, Italy
• Hospital Universitario de A Coruna — A Coruña, Spain

Full record on ClinicalTrials.gov

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