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



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:September 18, 2015
End Date:March 25, 2019

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A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

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.


Inclusion Criteria:

1. Participants with advanced solid tumor that is not amenable to surgical resection or
other approved therapeutic options.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

3. 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).

4. All participants must consent to provide archived diagnostic formalin-fixed paraffin
embedded (FFPE) tumor tissue and on study biopsies.

5. Participant has adequate bone marrow, renal, hepatic and cardiac function.

6. Women of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of treatment.

Exclusion Criteria:

1. Participant has received anticancer therapy or any investigational therapy within a
period of 21 days prior to the first dose of ABBV-085.

2. 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.

3. Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for
alopecia.

4. Participant has ongoing hemolysis.

5. Major surgery within <=28 days prior to the first dose of ABBV-085.

6. Clinically significant uncontrolled condition(s).

7. Participant has history of major immunologic reaction to any auristatin-based and /or
Immunoglobulin G (IgG) containing agent.
We found this trial at
17
sites
New York, New York 10016
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Aurora, CO
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Boston, Massachusetts 02215
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Boston, MA
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Chicago, Illinois 60637
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Chicago, IL
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Dallas, TX
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Durham, North Carolina 27710
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Durham, NC
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8503 Arlington Boulevard
Fairfax, Virginia 22031
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Fairfax, VA
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Greenville, South Carolina 29605
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Greenville, SC
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Houston, Texas 77030
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Houston, TX
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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Huntersville, NC
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Los Angeles, CA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
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Phoenix, AZ
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Saint Louis, MO
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4383 Medical Drive
San Antonio, Texas 78229
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San Antonio, TX
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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Villejuif, Ile-de-France 94805
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Villejuif,
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