A Study of ABT-165 in Subjects With Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/23/2019
Start Date:August 8, 2013
End Date:March 19, 2020
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and
preliminary efficacy of ABT-165 when administered as monotherapy and in combination with
paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without
paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed
and for Cohorts C and D are recruiting.


Inclusion Criteria:

- Subject must have advanced solid tumor that is not amenable to surgical resection or
other approved therapeutic options that have demonstrated clinical benefit.

- Subject has adequate bone marrow, renal, hepatic and coagulation function.

- Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors
(RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including
but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).

- Women of childbearing potential must have a negative serum pregnancy test at the
screening visit and a negative urine pregnancy test at baseline prior to the first
dose of study drug. Female subject considered not of childbearing potential must be
documented as being surgically sterile or post-menopausal for at least 1 year. Women
of childbearing potential and men must agree to use adequate contraception.

- Subjects in the combination therapy cohorts must meet the above inclusion criteria and
be eligible to receive paclitaxel or FOLFIRI per most current prescribing information,
or at the discretion of the Investigator. Subjects in the combination therapy cohorts
who are to receive ABBV-181, an anti-PD1 antibody, must also meet other criteria
described in the Protocol.

Exclusion Criteria:

- Subject has received anticancer therapy including chemotherapy, radiation therapy,
immunotherapy, biologic, or any investigational therapy within a period of 21 days or
anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.

- Subject has uncontrolled metastases to the central nervous system (CNS).

- Subject has unresolved clinically significant toxicities from prior anticancer
therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
or higher.

- Subject has history (within previous 5 years) of clinically significant pulmonary
hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic
heart failure, cardiomyopathy, myocardial infarction, unstable/severe angina pectoris,
cardiac arrhythmia requiring medication, coronary/peripheral artery bypass graft,
aneurysm or aneurysm repair, angioplasty, cerebrovascular accident, transient ischemic
attack or the left ventricular ejection fraction (LVEF) less than 50%.

- Subjects enrolled on the combination therapy phase must not meet the above exclusion
criteria and must be eligible to receive paclitaxel or FOLFIRI per most current
prescribing information, or at the discretion of the Investigator. Subjects receiving
ABBV-181 must not meet other exclusion criteria described in the Protocol.
We found this trial at
10
sites
8940 Wood Sage Road
Peoria, Illinois 61615
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Peoria, 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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1345 Unity Place
Lafayette, Indiana 47905
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Lafayette, IN
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Los Angeles, CA
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Nashville, TN
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Sacramento, California 95817
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Sacramento, CA
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Scottsdale, AZ
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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Stanford, California 94305
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Stanford, CA
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