A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
NCT ID: NCT02955251
Last Updated: 2020-07-20
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
61 participants
INTERVENTIONAL
2016-11-18
2019-10-29
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 1
ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Arm A, B, and C
Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Arm D
Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Arm 2
ABBV-428 plus nivolumab.
ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Interventions
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ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 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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HonorHealth Research Institute - Pima /ID# 155461
Scottsdale, Arizona, United States
UC Davis Comprehensive Cancer Center - Main /ID# 154439
Sacramento, California, United States
University of Chicago /ID# 154440
Chicago, Illinois, United States
Fox Chase Cancer Center /ID# 170665
Philadelphia, Pennsylvania, United States
Greenville Hospital System /ID# 154437
Greenville, South Carolina, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 154441
Houston, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 154442
San Antonio, Texas, United States
Chris O'Brien Lifehouse /ID# 163131
Camperdown, New South Wales, Australia
Northern Cancer Institute /ID# 163132
St Leonards, New South Wales, Australia
Institut Bergonie /ID# 202391
Bordeaux, Gironde, France
Hopital de la Timone /ID# 162256
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Leon Berard /ID# 168072
Lyon, Rhone, France
Institut Curie /ID# 162258
Paris, Île-de-France Region, France
Gustave Roussy /ID# 162257
Villejuif, Île-de-France Region, France
National Taiwan Univ Hosp /ID# 169034
Taipei City, Taipei, Taiwan
Countries
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References
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Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015.
Other Identifiers
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2016-001461-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-819
Identifier Type: -
Identifier Source: org_study_id
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