ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
NCT ID: NCT02565758
Last Updated: 2019-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2015-09-18
2019-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A4 (ABBV-085)
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.
Arm A3 (ABBV-085)
ABBV-085 will be administered at every cycle (28-day cycles).
ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.
Interventions
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ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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References
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Ray U, Pathoulas CL, Thirusangu P, Purcell JW, Kannan N, Shridhar V. Exploiting LRRC15 as a Novel Therapeutic Target in Cancer. Cancer Res. 2022 May 3;82(9):1675-1681. doi: 10.1158/0008-5472.CAN-21-3734.
Other Identifiers
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2015-001645-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-394
Identifier Type: -
Identifier Source: org_study_id
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