A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

Study Identifier
M16-074
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Solid Tumors (General)
  • Study Drug
  • ABBV-368
  • ABBV-181
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

    Study Locations

    Location
    Status
    Location
    Moores Cancer Center at UC San Diego /ID# 201334
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    University of California, Davis Comprehensive Cancer Center /ID# 201342
    Sacramento, California, United States, 95817
    Status
    Not applicable
    Location
    Stanford University /ID# 206949
    Stanford, California, United States, 94305
    Status
    Not applicable
    Location
    Yale University /ID# 207895
    New Haven, Connecticut, United States, 06510
    Status
    Not applicable
    Location
    Carolina BioOncology Institute /ID# 160786
    Huntersville, North Carolina, United States, 28078
    Status
    Not applicable
    Location
    Greenville Hospital System /ID# 160785
    Greenville, South Carolina, United States, 29605
    Status
    Not applicable
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