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ACTIVE NOT RECRUITING
NCT03821935
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Livmoniplimab

Liquid for intravenous infusion.

DRUG

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