ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Carcinoma of the Breast

In brief

This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

Key facts

Study ID

NCT02565758

Run by

AbbVie

People needed

85

Starts

2015-09-18

Expected to finish

2019-03-25

Last updated by the study team

2019-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens:
• Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN).
• All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
• Participant 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.

You may not qualify if…

• Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
• Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have 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.
• Participant has ongoing hemolysis.
• Major surgery within <=28 days prior to the first dose of ABBV-085.
• Clinically significant uncontrolled condition(s).
• Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.

Where it is running

• Mayo Clinic Arizona /ID# 148582 — Phoenix, Arizona, United States
• Scottsdale Healthcare /ID# 151349 — Scottsdale, Arizona, United States
• University of California, Los Angeles /ID# 148586 — Los Angeles, California, United States
• Univ of Colorado Cancer Center /ID# 148581 — Aurora, Colorado, United States
• University of Chicago /ID# 148579 — Chicago, Illinois, United States
• Dana-Farber Cancer Institute /ID# 143782 — Boston, Massachusetts, United States
• Washington University-School of Medicine /ID# 151348 — St Louis, Missouri, United States
• NYU Langone Medical Center /ID# 150786 — New York, New York, United States
• Duke Univ Med Ctr /ID# 148200 — Durham, North Carolina, United States
• Carolina BioOncology Institute /ID# 148583 — Huntersville, North Carolina, United States
• University of Pennsylvania /ID# 148576 — Philadelphia, Pennsylvania, United States
• Greenville Hospital System /ID# 148652 — Greenville, South Carolina, United States
• Mary Crowley Cancer Research /ID# 148580 — Dallas, Texas, United States
• Univ TX, MD Anderson /ID# 147681 — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics /ID# 141715 — San Antonio, Texas, United States
• Virginia Cancer Specialists /ID# 148584 — Fairfax, Virginia, United States
• Gustave Roussy /ID# 150300 — Villejuif, Île-de-France Region, France
• Hospital Univ Ramon y Cajal /ID# 150799 — Madrid, Spain
• Fundacion Jimenez Diaz /ID# 148564 — Madrid, Spain
• Hosp Univ Madrid Sanchinarro /ID# 146039 — Madrid, Spain

Full record on ClinicalTrials.gov

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