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NCT04041310 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor, Adult, sponsored by Nouscom SRL.

Active
Registry status
Phase 1
Development phase
115
Enrollment target
20
Study locations

NCT04041310 is a Phase 1 study of Solid Tumor, Adult that is active but no longer recruiting, run by Nouscom SRL. The registered enrollment target is 115 participants, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT04041310, a Phase 1 study of Solid Tumor, Adult, is active but no longer recruiting, sponsored by Nouscom SRL.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
115 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Solid Tumor, Adult

Interventions

  • BIOLOGICAL GAd-209-FSP low dose
  • BIOLOGICAL MVA-209-FSP low dose
  • BIOLOGICAL GAd-209-FSP high dose
  • BIOLOGICAL MVA-209-FSP high dose
  • BIOLOGICAL GAd20-209-FSP, RP2D

Study Locations (20)

Other

  • Cliniques Universitaires Saint-Luc - Centre du Cancer - Brussels
  • Centre Hospitalier de l'Ardenne - Libramont - Clinique du Sein - Libramont
  • CHU de Liège - Liège
  • Mount Sinai Hospital - Toronto
  • Princess Margaret Cancer Center - Toronto
  • Aorn Sg Moscati - Avellino
  • Candiolo cancer Center,FPO IRCCS - Candiolo

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope Comprehensive Cancer Center - Irvine
  • USC Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Comprehensive Cancer Center - Newport Beach

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo
  • NYU Langone Medical Center - New York
  • Weill Cornell Medicine / New York-Presbyterian Hospital - New York

Florida

  • Mt. Sinai - Miami Beach
  • Boca Raton Clinical Research - Plantation

Indiana

  • Goshen Center for Cancer Care - Goshen

Maryland

  • Johns Hopkins University - Baltimore

Missouri

  • Washington University School of Medicine, Division of Oncology - St Louis

Texas

  • MD Anderson Cancer Center (MDACC) - Houston

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2019-10-21
Est. Completion 2026-10-30
Phase Phase 1

Sponsor

Nouscom SRL

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04041310

The ClinicalTrials.gov registry entry for NCT04041310 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target (39% lower). The listed sponsor is Nouscom SRL, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor, Adult appearing as the primary indexed condition, and to 5 interventions - of which GAd-209-FSP low dose is the first listed.

NCT04041310 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT04041310 about?

NCT04041310 is a clinical study titled "Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors". 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 pembrolizum...

What is the current status of trial NCT04041310?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2019-10-21. Estimated completion is 2026-10-30.

What conditions does trial NCT04041310 study?

This clinical trial studies the following conditions: Solid Tumor, Adult.

What interventions are being tested in trial NCT04041310?

The interventions under investigation include: GAd-209-FSP low dose (BIOLOGICAL), MVA-209-FSP low dose (BIOLOGICAL), GAd-209-FSP high dose (BIOLOGICAL), MVA-209-FSP high dose (BIOLOGICAL), GAd20-209-FSP, RP2D (BIOLOGICAL).

Who is sponsoring clinical trial NCT04041310?

This trial is sponsored by Nouscom SRL, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04041310 being conducted?

This trial has 20 study locations across California, Florida, Indiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.