For Healthcare Professionals

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

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About the study

Ref: Protocol v7.0, dated 23Mar2022. 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

for Cohorts A and B (Phase I): In order to be eligible for participation in the Phase I of this trial (Cohorts A and B) the subject must:

  1. Have previously proven microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status (confirmatory testing is not required).
  2. dMMR/MSI Testing
  3. Subjects are eligible to the combined treatment in Cohorts A and B based on previous diagnosis for MSI status. MSI status diagnosis should have been performed locally by CLIA certified immunohistochemistry (IHC) or NGS or PCR based tests. A. Subjects 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 B. Subjects 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).
  4. Be ≥18 years of age on day of signing informed consent. 4. Have a life expectancy of at least 6 months. 5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  5. Have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If subject received major surgery or radiation therapy they must have recovered from the toxicity and/or complications from the intervention.
  6. Have adequate hematological and blood chemistry values as indicated in Table 1. Table 1: Adequate Hematological and Chemistry Lab Values for Phase I Absolute neutrophil count (ANC) >1000 / mm3 Platelets >100,000 / mm3 Hemoglobin >9 g/dL or >5.6 mmol/L
  7. 2 weeks without transfusions AST or ALT ≤2.5 x ULN Subject with liver metastases ≤5 ULN Alkaline phosphatase ≤5 x ULN Creatinine Clearance (Calculated by Cockcroft Gault glomerular filtration rate estimation) ≥50 mL/min 8. Not previously treated with a (licensed or experimental) anti-PD-1 or anti-PD-L1 checkpoint inhibitor.
  8. Must agree to have a first biopsy at baseline from a lesion that can be biopsied with an acceptable clinical risk (as judged by the Investigator in discussion with the interventional radiologist or endoscopist). An older (not older than 6 months) formalin-fixed paraffin-embedded (FFPE) specimen from locations not radiated prior to biopsy can be accepted.
  9. Must agree to have a second on-treatment biopsy that will be taken only if not representing an unacceptable clinical risk and/or if technically feasible as judged by the Investigator in discussion with the interventional radiologist or endoscopist.
  10. Participants with measurable disease per RECIST version 1.1. 12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive, or cannot be confirmed as negative, a serum pregnancy test will be required.
  11. Females of reproductive potential must agree to use effective contraception for the entire study duration up to 4 months after the last dose of pembrolizumab and 60 days after the last dose of vaccine (see paragraph 6.10).
  12. Male subjects of childbearing potential must agree to use effective contraception starting with the first dose of vaccine through 60 days after the last dose of vaccine (see paragraph 6.10).
  13. Ability to understand and willingness to sign a written Informed Consent form.

EXCLUSION CRITERIA

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    Study Locations

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    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall +39 06 96036299Email iconEmail Study Center

    Study’s details


    Contition

    Solid Tumor, Adult

    Age (in years)

    18 - 200

    Phase

    Phase 1/Phase 2

    Participants needed

    115

    Est. Completion Date

    Jul 2026

    Treatment type

    Interventional


    Sponsor

    Nouscom SRL

    ClinicalTrials.gov identifier

    NCT04041310

    Study number

    NOUS-209-01

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