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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

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