Tumeurs solides

  • Accueil
  • Tumeurs solides
  • SGNDV-005

TITRE (EN) A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
PROTOCOLE ID SGNDV-005
CLINICAL TRIAL.gov ID NCT06003231
TYPE(S) DE CANCER Tumeurs solides
PHASE Phase II
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Vincent Castonguay
COORDONATEUR(RICE) Maryse Gingras
maryse.gingras@chudequebec.ca
418-525-4444 poste 15781
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)

  • Cohort 1: HNSCC

    • Pathologically-documented squamous cell carcinoma of the head and neck with primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and larynx
    • Unresectable locally recurrent or metastatic stage disease

    • Prior therapies:

      • Participants must have disease progression after treatment with a platinum-based therapy
      • No more than 1 line of cytotoxic chemotherapy for advanced disease

  • Cohort 2: NSCLC

    • Pathologically documented NSCLC
    • Unresectable locally-advanced or metastatic stage disease

    • Prior therapies

      • Must have progressed during or after a platinum-based therapy or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease
      • Must have received prior anti-PD(L)1 therapy, unless contraindicated
      • No more than 2 prior lines of cytotoxic chemotherapy for advanced disease

  • Cohort 3: Ovarian Cancer

    • Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin
    • Unresectable locally-advanced or metastatic stage disease

    • Prior therapies

      • Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence)
      • Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease
      • May have received prior anti-PD(L)1 therapy

  • Cohort 4: Endometrial Cancer

    • Must have pathologically documented adenocarcinoma of the endometrium
    • Must have unresectable locally-advanced or metastatic stage disease.

    • Prior therapies

      • Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease
      • Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease
      • May have received prior anti-PD(L)1 therapy
  • HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue
  • Measurable disease per RECIST v1.1 criteria as assessed by the investigator
  • Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
CRITÈRES D'EXCLUSION (EN)
  • Prior treatment with an MMAE-containing agent.
  • Previous treatment with HER2-directed ADCs
  • Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
  • History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  • Active untreated CNS or leptomeningeal metastasis