A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer

Study Identifier
M17-327
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Lung Cancer - Small Cell Lung Cancer (SCLC)
  • Study Drug
  • ABBV-011
  • Budigalimab
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 207295
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Highlands Oncology Group, PA /ID# 207176
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    University of California, Davis Comprehensive Cancer Center /ID# 207548
    Sacramento, California, United States, 95817
    Status
    Not applicable
    Location
    Yale School of Medicine /ID# 207559
    New Haven, Connecticut, United States, 06519
    Status
    Not applicable
    Location
    University of Iowa Hospitals and Clinics /ID# 207560
    Iowa City, Iowa, United States, 52242
    Status
    Not applicable
    Location
    University of Kentucky Chandler Medical Center /ID# 208217
    Lexington, Kentucky, United States, 40536
    Status
    Not applicable
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