A 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 (AbbVie M19-345)

Brief description of study

The purpose of the study is to look at safety and efficacy of study drug ABBV-151 alone and in combination with study drug ABBV-181. We want to know how your body tolerates both study drugs, how effective they may be, and how they are taken up by your body, when administered single dose and after multiple doses over the course of the study. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1(PD-1). ABBV-151 is a human IgG4 (S228P)/k mAb that specifically binds to the GARP-TGF-ß1 complex, blocking release of active TGF-ß1.The study drugs are investigational, which means that they have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.


Clinical Study Identifier: s19-01835
ClinicalTrials.gov Identifier: NCT03821935
Principal Investigator: Arjun Vasant Balar.


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