Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT03821935
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint Louis, Missouri, United States
NYU Langone Medical Center /ID# 209822, 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
NEXT Oncology /ID# 208930, San Antonio, Texas, 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, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Princess Margaret Cancer Centre /ID# 209423, Toronto, Ontario, Canada
CHU Toulouse - Hopital Purpan /ID# 218667, TOULOUSE Cedex 9, Haute-Garonne, France
Centre Leon Berard /ID# 218515, Lyon CEDEX 08, Rhone, France
Institut Gustave Roussy /ID# 218668, Villejuif Cedex, Val-de-Marne, France
Centre Jean Perrin /ID# 218669, Clermont Ferrand, , France
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
Rabin Medical Center /ID# 258479, Haifa, , Israel
Hadassah Medical Center-Hebrew University /ID# 257918, Jerusalem, , Israel
National Cancer Center Hospital East /ID# 224808, Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 209421, Chuo-ku, Tokyo, Japan
Gachon University Gil Medical Center /ID# 257572, Incheon, Gyeonggido, Korea, Republic of
Chonnam National University Hwasun Hospital /ID# 257573, Hwasun-gun, Jeonranamdo, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 218512, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital /ID# 257574, Seoul, , Korea, Republic of
Seoul National University Hospital /ID# 218513, Seoul, , Korea, Republic of
Pan American Center for Oncology Trials, LLC /ID# 217475, Rio Piedras, , Puerto Rico
Hospital Clinic de Barcelona /ID# 221106, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 220928, Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 221107, Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257634, Kaohsiung, , Taiwan
China Medical University Hospital /ID# 218492, Taichung, , Taiwan
National Taiwan University Hospital /ID# 218490, Taipei City, , Taiwan
Taipei Veterans General Hosp /ID# 257635, Taipei, , Taiwan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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