SGNLVA-005

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

Objective

This trial is designed to assess the antitumor activity, safety, and tolerability of LV for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled:

Study Arms

  • Experimental: Ladiratuzumab Vedotin

Eligibility

All Cohorts

  • Measurable disease according to RECIST v1.1 as assessed by the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1

Cohort 1: SCLC

  • Must have extensive-stage disease
  • Must have disease progression during or following prior platinum-based systemic chemotherapy for extensive-stage disease
  • No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
  • No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
  • May have received prior anti-PD(L)1 therapy

Cohort 2: NSCLC-squamous

  • Must have unresectable locally advanced or metastatic disease
  • Must have disease progression during or following systemic therapy
    • Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
    • Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease.
  • Participants with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are not eligible
  • No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
  • Must have received prior anti-PD(L)1 therapy, unless contraindicated

Cohort 3: NSCLC-nonsquamous

  • Must have unresectable locally advanced or metastatic disease
  • Must have disease progression during or following systemic therapy
    • Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
    • Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease.
  • Participants with known EGFR, ALK, ROS, BRAF, tropomyosin receptor kinase (TRK), or other actionable mutations are not eligible
  • Must have had prior platinum-based chemotherapy
  • No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
  • Must have received prior anti-PD(L)1 therapy, unless contraindicated

Cohort 5: esophageal-squamous

  • Must have unresectable locally advanced or metastatic disease
  • Must have disease progression during or following systemic therapy
  • Must have had prior platinum-based chemotherapy
  • No more than 1 line of cytotoxic chemotherapy for their advanced disease

Cohort 6: gastric and GEJ adenocarcinoma

  • Must have unresectable locally advanced or metastatic disease
  • Must have received prior platinum-based therapy
  • Must have disease progression during or following systemic therapy
  • Participants with known human epidermal growth factor receptor 2 (HER2) overexpression must have received prior HER2-targeted therapy
  • No more than 1 line of prior cytotoxic chemotherapy for their advanced disease
  • Participants may have received prior anti-PD(L)1 therapy, unless contraindicated

NCT ID

NCT04032704