Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02565758

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 20 Locations for this study

See Locations Near You

Mayo Clinic Arizona /ID# 148582
Phoenix Arizona, 85054, United States
Scottsdale Healthcare /ID# 151349
Scottsdale Arizona, 85258, United States
University of California, Los Angeles /ID# 148586
Los Angeles California, 90095, United States
Univ of Colorado Cancer Center /ID# 148581
Aurora Colorado, 80045, United States
University of Chicago /ID# 148579
Chicago Illinois, 60637, United States
Dana-Farber Cancer Institute /ID# 143782
Boston Massachusetts, 02215, United States
Washington University-School of Medicine /ID# 151348
Saint Louis Missouri, 63110, United States
NYU Langone Medical Center /ID# 150786
New York New York, 10016, United States
Duke Univ Med Ctr /ID# 148200
Durham North Carolina, 27710, United States
Carolina BioOncology Institute /ID# 148583
Huntersville North Carolina, 28078, United States
University of Pennsylvania /ID# 148576
Philadelphia Pennsylvania, 19104, United States
Greenville Hospital System /ID# 148652
Greenville South Carolina, 29605, United States
Mary Crowley Cancer Research /ID# 148580
Dallas Texas, 75230, United States
Univ TX, MD Anderson /ID# 147681
Houston Texas, 77030, United States
South Texas Accelerated Research Therapeutics /ID# 141715
San Antonio Texas, 78229, United States
Virginia Cancer Specialists /ID# 148584
Fairfax Virginia, 22031, United States
Gustave Roussy /ID# 150300
Villejuif Ile-de-France, 94805, France
Hospital Univ Ramon y Cajal /ID# 150799
Madrid , 28034, Spain
Fundacion Jimenez Diaz /ID# 148564
Madrid , 28040, Spain
Hosp Univ Madrid Sanchinarro /ID# 146039
Madrid , 28050, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02565758

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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