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Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor: AbbVie
Summary
The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.
Official title: A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2019-02-21
Completion Date
2027-06
Last Updated
2025-05-25
Healthy Volunteers
No
Conditions
Interventions
Livmoniplimab
Liquid for intravenous infusion.
Budigalimab
Lyophilized powder for solution for intravenous infusion.
Locations (64)
Highlands Oncology Group, PA /ID# 218942
Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 265620
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785
Irvine, California, United States
Yale University School of Medicine /ID# 208356
New Haven, Connecticut, United States
AdventHealth Celebration /ID# 224860
Celebration, Florida, United States
Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953
Orlando, Florida, United States
Indiana Univ School Medicine /ID# 208384
Indianapolis, Indiana, United States
Community Health Network, Inc. /ID# 257032
Indianapolis, Indiana, United States
Univ Michigan Med Ctr /ID# 221129
Ann Arbor, Michigan, United States
Washington University-School of Medicine /ID# 259684
St Louis, Missouri, United States
Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171
Billings, Montana, United States
NYU Langone Medical Center /ID# 209822
New York, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 264653
New York, New York, United States
Carolina BioOncology Institute /ID# 208358
Huntersville, North Carolina, United States
The Ohio State University - The James /ID# 217611
Columbus, Ohio, United States
Ou Health - Stephenson Cancer Center /ID# 268826
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute (SMO/Network/Consortium) /ID# 264900
Nashville, Tennessee, United States
Renovatio clinical /ID# 265109
El Paso, Texas, United States
NEXT Oncology /ID# 208930
San Antonio, Texas, United States
Renovatio Clinical /ID# 265054
The Woodlands, Texas, United States
University of Washington Medical Center /ID# 268854
Seattle, Washington, United States
Chris O'Brien Lifehouse /ID# 213236
Camperdown, New South Wales, Australia
Icon Cancer Centre /ID# 224961
South Brisbane, Queensland, Australia
Cliniques Universitaires UCL Saint-Luc /ID# 218466
Brussels, Brussels Capital, Belgium
University Health Network_Princess Margaret Cancer Centre /ID# 209423
Toronto, Ontario, Canada
CHU Toulouse - Hopital Purpan /ID# 218667
Toulouse, Haute-Garonne, France
Centre Leon Berard /ID# 218515
Lyon, Rhone, France
Institut Gustave Roussy /ID# 218668
Villejuif, Val-de-Marne, France
Centre Jean Perrin /ID# 218669
Clermont-Ferrand, France
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung /ID# 269587
Essen, North Rhine-Westphalia, Germany
Rambam Health Care Campus /ID# 222198
Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 209037
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 222199
Tel Aviv, Tel Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 257918
Jerusalem, Israel
Rabin Medical Center /ID# 258479
Petah Tikva, Israel
Istituto Europeo Di Oncologia /Id# 266053
Milan, Milano, Italy
National Cancer Center Hospital East /ID# 224808
Kashiwa-shi, Chiba, Japan
Hyogo Cancer Center /ID# 272553
Akashi-shi, Hyōgo, Japan
National Cancer Center Hospital /ID# 209421
Chuo-ku, Tokyo, Japan
Jagiellonskie Centrum Innowacji Sp. z o.o. /ID# 266194
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 266147
Warsaw, Masovian Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki /ID# 266324
Lodz, Łódź Voivodeship, Poland
Pan American Center for Oncology Trials, LLC /ID# 217475
Rio Piedras, Puerto Rico
Gachon University Gil Medical Center /ID# 257572
Incheon, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 257573
Hwasun-gun, Jeonranamdo, South Korea
Korea University Anam Hospital /ID# 257574
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 218513
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 266799
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 265865
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 218512
Seoul, South Korea
Clinica Universidad de Navarra - Pamplona /ID# 266632
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron /ID# 265290
Barcelona, Spain
Hospital Clinic de Barcelona /ID# 221106
Barcelona, Spain
Clinica Universidad de Navarra - Madrid /ID# 265299
Madrid, Spain
Hospital Universitario Ramón y Cajal /ID# 265298
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 220928
Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 265294
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 221107
Valencia, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 265560
Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 218490
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257634
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 218492
Taichung, Taiwan
Taipei Veterans General Hosp /ID# 257635
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 265551
Taoyuan, Taiwan