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Trial Summary

Protocol No.CTO-M19-345
Principal InvestigatorMiller, Kathy
PhasePhase I
Age GroupAdult
TitleA Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination with ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumors
DescriptionThe study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as monotherapy and in combination with ABBV-181 as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with ABBV-181. The study will consist of 2 phases: dose escalation and dose expansion.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Subject has adequate bone marrow, renal, hepatic, and coagulation function. Must have a viral status consistent with the requirements described in the protocol specific to type of cancer and stage of study (Dose Escalation or Dose Expansion).
For a full list of participation criteria, please visit
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632