A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors



Status:Recruiting
Healthy:No
Age Range:18 - 99
Updated:3/13/2019
Start Date:November 18, 2016
End Date:December 28, 2020
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2
dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)
profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in
participants with advanced solid tumors.


Inclusion Criteria:

- Participants must have an advanced solid tumor that has progressed on standard
therapies known to provide clinical benefit or the participants are intolerant to such
therapies.

- Participants have adequate bone marrow, renal, hepatic and coagulation function.

- For all dose expansion arms, participants must have measurable disease per Response
Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

- Participants in combination therapy cohorts must have an advanced solid tumor where
the use of nivolumab is standard therapy.

Exclusion Criteria:

- Active or prior documented autoimmune disease in the last 2 years. Participants with
childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or
psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.

- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose (with certain exceptions).

- History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic
leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.

- Confirmed positive test results for human immunodeficiency virus (HIV), or
participants with chronic or active hepatitis B or C. Participants who have a history
of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy
may be enrolled.

- Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis
(or any other unresolved or symptomatic adverse event in the last 3 months) while
receiving immunotherapy.

- Male participants who are considering fathering a child or donating sperm during the
study or for at least 3 or 5 months (for monotherapy and combination therapy
participants, respectively) after the last dose of study drug.
We found this trial at
8
sites
4383 Medical Drive
San Antonio, Texas 78229
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Camperdown, New South Wales
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Camperdown,
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Chicago, Illinois 60637
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Chicago, IL
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Greenville, South Carolina 29605
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Greenville, SC
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Houston, TX
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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Sacramento, California 95817
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Sacramento, CA
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Scottsdale, AZ
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