Perlmutter Cancer Center

This is a Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of livmoniplimab (ABBV-151) as a Single Agent and in Combination with budigalimab (ABBV-181) in Subjects with Locally Advanced or Metastatic Solid Tumors (AbbVie M19-345) The trial will consist of 2 parts: dose escalation and dose expansion. In the dose escalation portion, a BOIN design based on the cumulative number of subjects who experience a dose-limiting toxicity (DLT) at the current dose level will be utilized to guide dose escalation with 7 dose levels of ABBV-151 (dose levels 1 to 7) being considered. The number of subjects enrolled in each cohort will be based on a dose escalation scheme using BOIN design. It is anticipated that approximately 46 subjects will be enrolled in dose escalation. All dose expansion arms will only begin after the RP2D/maximum tolerated dose (MTD) or maximum administered dose (MAD) has been defined for both ABBV-151 monotherapy and ABBV-151 + ABBV-181 combination therapy. Dose expansion will include 6 cohorts with 5 tumor types under evaluation (TNBC, pancreatic adenocarcinoma, urothelial cancer, HCC, and HNSCC). Subjects with TNBC will be randomized 1:1 to Cohorts 1 or 2 to enable comparability of data and minimization of subject selection bias. Standard statistical, clinical, and laboratory procedures will be utilized in this study. All efficacy measurements are standard for assessing disease activity in subjects with solid tumors. All clinical and laboratory procedures are also standard and generally accepted.