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Protocol No. UW19077

Principal Investigator Bruce, Justine

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

Objective We are studying ladiratuzumab vedotin(LV) to find out if it works for solid tumor cancers and what kind of side effects it causes. A side effect is anything the drug does to your body besides treating your disease. We don't yet know if ladiratuzumab vedotin(LV) is better or worse than other treatments. Learning about the side effects of ladiratuzumab vedotin(LV) and how it works will help us understand if ladiratuzumab vedotin(LV) is better or worse than other treatments

Treatment Ladiratuzumab vedotin(LV) will be administered at a dose of 2.5 mg/kg as a 30 minute IV infusion every 21 days. Any subject receiving greater than 200 mg LV per cycle (weight greater than 80 kg) is required to receive prophylactic G-CSF. For subjects weighing more than 100 kg, dosing will be capped at 250 mg per infusion

Description Phase II Study of Ladiratuzumab vedotin(LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

Key Eligibility
  • Cohort 1, SCLC; Cohort 2, NSCLC-squamous; Cohort 3, NSCLC-nonsquamous; Cohort 4, HNSCC; Cohort 5, esophageal-squamous; and Cohort 6, gastric and GEJ adenocarcinoma all have specific requirements that are defined by the protocol
  • Measureable disease according to RECIST v1.1
  • 18 years bof age or older
  • ECOG performance status of 0-1
  • Adequate organ function as defined by the protocol
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Available and adequate archival baseline tumor sample is required or a fresh biopsy sample is required
    EXCLUSION
  • Subjects with known active central nervous system (CNS) lesions including leptomeningeal metastasis are excluded. Subjects with symptoms concerning for active CNS disease must have been evaluated and treated per institutional standard of care. Subjects with definitively treated brain metastasis (surgery and/or radiotherapy) are eligible if they meet requirements defined by the protocol
  • Active viral, bacterial, or fungal infection requiring systemic treatment within 7 days prior to the first dose of LV
  • Ongoing sensory or motor neuropathy of Grade greater than or equal to 2
  • Subjects with known and untreated hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Subjects are eligible if they are on a stable anti-viral treatment or have received curative therapy
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure, Class III-IV, by New York Heart Association criteria within 6 months prior to study enrollment

  • Applicable Disease Sites Esophagus; Head and Neck; Lung; Stomach

    Status Open

    Participating Institutions UW Hospital and Clinics