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

NCT04041310 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-02-13

No results posted yet for this 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

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

GAd-209-FSP low dose

GAd20-209-FSP IP, low dose

BIOLOGICAL

MVA-209-FSP low dose

MVA-209-FSP IP, low dose

BIOLOGICAL

GAd-209-FSP high dose

GAd20-209-FSP IP, high dose

BIOLOGICAL

MVA-209-FSP high dose

MVA-209-FSP IP, high dose

BIOLOGICAL

GAd20-209-FSP, RP2D

GAd20-209-FSP IP, RP2D

BIOLOGICAL

MVA-209-FSP, RP2D

MVA-209-FSP IP, RP2D

DRUG

KEYTRUDA®

anti-PD-1 checkpoint inhibitor (200 mg; Q3W)

Sponsors & Collaborators

Principal Investigators

  • Sven Gogov, MD · Nouscom SRL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2026-10-30
Completion
2026-10-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041310 on ClinicalTrials.gov