Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

Study Identifier
M19-345
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-508281-15-00
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Study Details

Medical Condition
  • Solid Tumors (General)
  • Study Drug
  • Livmoniplimab
  • Budigalimab
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

    Study Locations

    Location
    Status
    Location
    Highlands Oncology Group, PA /ID# 218942
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    City of Hope National Medical Center /ID# 265620
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    Yale University School of Medicine /ID# 208356
    New Haven, Connecticut, United States, 06510
    Status
    Not applicable
    Location
    AdventHealth Celebration /ID# 224860
    Celebration, Florida, United States, 34747-4970
    Status
    Not applicable
    Location
    Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953
    Orlando, Florida, United States, 32804
    Status
    Not applicable
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