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ACTIVE NOT RECRUITING Phase 1

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

NCT04041310 · View on ClinicalTrials.gov ↗

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

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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nouscom SRL, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04041310 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04041310?

This trial is sponsored by Nouscom SRL, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial