Budigalimab

Generic Name: Budigalimab

Drug Type: Biotech

CAS Number: 2098225-93-3

Unique Ingredient Identifier: 6VDO4TY3OO

Background: Budigalimab is under investigation in clinical trial NCT04807972 (Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 Is Administered in Combination With IV Modified FOLFIRINOX (Mffx) With or Without IV Budigalimab Compared to Mffx in Adult Participants With Untreated Pancreatic Cancer Metastasis).

Clinical Trials

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab

Phase 1

Recruiting

Conditions: Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Micro Satellite Stable Colorectal Cancer
Gastric/Esophageal Cancer
High-Grade Serous Ovarian Cancer
Pancreatic Cancer
Triple Negative Breast Cancer

Interventions: Drug: Azirkitug
Drug: Budigalimab
Drug: Bevacizumab

First Posted Date: 2021-08-13

Last Posted Date: 2025-05-20

Lead Sponsor: AbbVie

Target Recruit Count: 512

Registration Number: NCT05005403

Locations: 🇮🇱
Rambam Health Care Campus /ID# 238333, Haifa, H_efa, Israel
🇮🇱
Hadassah Medical Center-Hebrew University /ID# 252287, Jerusalem, Israel
🇮🇱
Rabin Medical Center /ID# 250497, Petah Tikva, Israel

and more 26 locations

Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)

Phase 1

Completed

Conditions: Human Immunodeficiency Virus (HIV)

Interventions: Drug: Budigalimab
Drug: Placebo

First Posted Date: 2021-03-16

Last Posted Date: 2022-10-17

Lead Sponsor: AbbVie

Target Recruit Count: 33

Registration Number: NCT04799353

Locations: 🇺🇸
Central Texas Clinical Research /ID# 223937, Austin, Texas, United States
🇺🇸
Franco Felizarta, Md /Id# 223931, Bakersfield, California, United States
🇺🇸
Ruane Clinical Research Group /ID# 224496, Los Angeles, California, United States

and more 7 locations

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

Phase 1

Completed

Conditions: Human Immunodeficiency Virus (HIV)
HIV-1
HIV Infection

Interventions: Drug: Placebo
Drug: ABBV-181

First Posted Date: 2020-01-10

Last Posted Date: 2023-03-09

Lead Sponsor: AbbVie

Target Recruit Count: 41

Registration Number: NCT04223804

Locations: 🇺🇸
Franco Felizarta, Md /Id# 215721, Bakersfield, California, United States
🇺🇸
Ruane Clinical Research Group /ID# 224866, Los Angeles, California, United States
🇺🇸
Quest Clinical Research /ID# 215796, San Francisco, California, United States

and more 20 locations

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Phase 1

Completed

Conditions: Advanced Solid Tumors Cancer

Interventions: Drug: ABBV-368
Drug: Tilsotolimod
Drug: Nab-paclitaxel
Drug: ABBV-181

First Posted Date: 2019-12-12

Last Posted Date: 2023-02-27

Lead Sponsor: AbbVie

Target Recruit Count: 30

Registration Number: NCT04196283

Locations: 🇺🇸
The University of Chicago Medical Center /ID# 217196, Chicago, Illinois, United States
🇺🇸
MD Anderson Cancer Center /ID# 214041, Houston, Texas, United States
🇺🇸
Norton Cancer Institute /ID# 216179, Louisville, Kentucky, United States

and more 23 locations

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumors
Cancer
Triple-Negative Breast Cancer (TNBC)
Non-small-cell-lung-cancer (NSCLC)
Metastatic Solid Tumors

Interventions: Drug: ABBV-927
Drug: ABBV-368
Drug: Carboplatin
Drug: ABBV-181
Drug: Nab-paclitaxel

First Posted Date: 2019-03-28

Last Posted Date: 2024-08-14

Lead Sponsor: AbbVie

Target Recruit Count: 150

Registration Number: NCT03893955

Locations: 🇪🇸
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806, Madrid, Spain
🇦🇺
Icon Cancer Centre /ID# 224084, South Brisbane, Queensland, Australia
🇺🇸
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072, Fort Wayne, Indiana, United States

and more 23 locations

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

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumors Cancer

Interventions: Drug: Livmoniplimab
Drug: Budigalimab

First Posted Date: 2019-01-30

Last Posted Date: 2025-05-22

Lead Sponsor: AbbVie

Target Recruit Count: 364

Registration Number: NCT03821935

Locations: 🇮🇱
Rabin Medical Center /ID# 258479, Petah Tikva, Israel
🇨🇳
Taipei Veterans General Hosp /ID# 257635, Taipei, Taiwan
🇨🇳
Linkou Chang Gung Memorial Hospital /ID# 265551, Taoyuan City, Taiwan

and more 61 locations

A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma

Phase 1

Terminated

Conditions: Head and Neck Cancer

Interventions: Drug: ABBV-927
Drug: ABBV-368
Drug: ABBV-181

First Posted Date: 2019-01-28

Last Posted Date: 2020-12-31

Lead Sponsor: AbbVie

Target Recruit Count: 3

Registration Number: NCT03818542

Locations: 🇺🇸
Massachusetts General Hospital /ID# 207392, Boston, Massachusetts, United States
🇺🇸
University of Michigan /ID# 210181, Ann Arbor, Michigan, United States
🇺🇸
MD Anderson Cancer Center /ID# 208749, Houston, Texas, United States

A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer

Phase 1

Completed

Conditions: Small Cell Lung Cancer

Interventions: Drug: ABBV-011
Drug: Budigalimab

First Posted Date: 2018-08-21

Last Posted Date: 2024-02-09

Lead Sponsor: AbbVie

Target Recruit Count: 132

Registration Number: NCT03639194

Locations: 🇺🇸
UH Cleveland Medical Center /ID# 207561, Cleveland, Ohio, United States
🇺🇸
The Ohio State University /ID# 207552, Columbus, Ohio, United States
🇺🇸
Highlands Oncology Group, PA /ID# 207176, Springdale, Arkansas, United States

and more 29 locations

SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers

Phase 1

Terminated

Conditions: Cancer

Interventions: Drug: SC-004
Drug: ABBV-181

First Posted Date: 2017-05-03

Last Posted Date: 2019-05-14

Lead Sponsor: AbbVie

Target Recruit Count: 24

Registration Number: NCT03138408

Locations: 🇺🇸
Highlands Oncology Group /ID# 209165, Fayetteville, Arkansas, United States
🇺🇸
City of Hope /ID# 202493, Duarte, California, United States
🇺🇸
The Ohio State University - Columbus /ID# 164089, Columbus, Ohio, United States

and more 9 locations

A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumors Cancer

Interventions: Drug: ABBV-368
Drug: ABBV-181

First Posted Date: 2017-03-07

Last Posted Date: 2022-04-28

Lead Sponsor: AbbVie

Target Recruit Count: 139

Registration Number: NCT03071757

Locations: 🇫🇷
Institut Gustave Roussy /ID# 165035, Villejuif Cedex, Val-de-Marne, France
🇫🇷
AP-HM - Hopital de la Timone /ID# 165036, Marseille CEDEX 05, Bouches-du-Rhone, France
🇺🇸
Carolina BioOncology Institute /ID# 160786, Huntersville, North Carolina, United States

and more 24 locations

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