Ensayos clínicos

Inclusion Criteria

• Advanced solid tumors not amenable to surgical resection or other approved therapeutic options
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens
• Non-evaluable or non-measurable cancers are eligible if they have a confirmed increase in tumor antigens ≥ 2 x upper limit of normal (ULN)
• Must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue, if available
• Has adequate bone marrow, renal, hepatic and cardiac function
• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment

Exclusion Criteria

• Has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085
• Has uncontrolled metastases to the central nervous system (CNS)
  • Brain metastases is eligible provided it has shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and not used steroids for at least 4 weeks prior to first dose of ABBV-085
• Unresolved adverse events ≥ Grade 2 from prior anticancer therapy, except for alopecia
• Has ongoing hemolysis
• Major surgery within ≤ 28 days prior to the first dose of ABBV-085
• Clinically significant uncontrolled condition(s)
• Has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent