A Study of ABBV-085, an Antibody Drug Conjugate, for Patients with Advanced Solid Cancer Tumors


About this study

The purpose of this study is to evaluate the safety and drug/body interactions of ABBV-085,  and to determine the recommended future study dose (alone or in combination with standard therapies) for people who have  advanced solid tumors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ramesh Ramanathan, M.D.

Closed for enrollment

Contact information:

Research Information Center


More information


Publications are currently not available

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