A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors

Study Identifier
M25-632
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2025-521607-48-00
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Study Details

Medical Condition
  • Head and Neck Cancer
  • Study Drug
  • ABBV-711
  • Budigalimab
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-711 as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors.

    ABBV-711 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-711 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 220 adult participants will be enrolled in the study across 40 sites worldwide.

    In part 1, oral ABBV-711 tablets will be given in escalating doses alone to participants with squamous (sq) tumors. In part 2 oral ABBV-711 tablets will be given at a selected dose from part 1 to participants with squamous non-small cell lung cancer (sqNSCLC), or head and neck squamous cell carcinoma (HNSCC). In part 3, oral ABBV-711 tablets will be given in escalating doses in combination with intravenously (IV) infused budigalimab to participants with sq tumors. In part 4 oral ABBV-711 tablets will be given at a selected dose from part 3 in combination with IV infused budigalimab to participants with sqNSCLC, or HNSCC. The estimated duration of the study is up to approximately 5 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent questionnaire, medical assessments, blood tests, and scans.

    Study Locations

    Location
    Status
    Location
    City Of Hope Comprehensive Cancer Center /ID# 276550
    Duarte, California, United States, 91030
    Status
    Recruiting
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
    Irvine, California, United States, 92618
    Status
    Recruiting
    Location
    University of Chicago Medical Center /ID# 276638
    Chicago, Illinois, United States, 60637
    Status
    Recruiting
    Location
    START Midwest /ID# 272505
    Grand Rapids, Michigan, United States, 49546
    Status
    Recruiting
    Location
    Carolina BioOncology Institute /ID# 272380
    Huntersville, North Carolina, United States, 28078
    Status
    Recruiting
    Location
    Next Oncology - Irving /ID# 276659
    Irving, Texas, United States, 75039
    Status
    Recruiting
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