9 active not recruiting, 7 completed, 7 terminated, 1 recruiting. 18 Phase 1, 7 Phase 2, 2 Phase 3.
By phase and status
Follow ABBV-181: new trials by email Literature Review of ABBV-181 trials Research Report on ABBV-181
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations Telisotuzumab Adizutecan, Budigalimab, Pembrolizumab - Non Small Cell Lung Carcinoma, c-MET Phase 1 / Phase 2 Recruiting 252 2025-03-06 2026-10-27 Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) Livmoniplimab, Budigalimab, Docetaxel - Urothelial Carcinoma Phase 2 Active not recruiting 150 2025-01-20 2025-08-11 A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Telisotuzumab Adizutecan, Budigalimab, Fluorouracil - Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma Phase 2 Active not recruiting 185 2024-12-13 2026-07-21 A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Livmoniplimab, Budigalimab - Hepatocellular Carcinoma (HCC) Phase 1 Terminated 3 2024-09-11 2026-10-21 Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Livmoniplimab, Budigalimab, Pembrolizumab - Non-Small Cell Lung Cancer Phase 2 / Phase 3 Active not recruiting 167 2024-04-10 2026-10-19 A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors ABBV-303, Budigalimab - Solid Tumors Phase 1 Terminated 27 2024-02-06 2025-10-27 A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC) Livmoniplimab, Budigalimab, Durvalumab - Hepatocellular Carcinoma Phase 2 / Phase 3 Active not recruiting 89 2024-01-11 2026-09-22 A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 Budigalimab, Placebo for Budigalimab, ABBV-382 - Human Immuno-deficiency Virus (HIV) Disease Phase 2 Terminated 163 2023-10-12 2025-10-29 Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC) Budigalimab, Livmoniplimab, Lenvatinib - Hepatocellular Carcinoma Phase 2 Active not recruiting 130 2023-09-21 2025-08-14 Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors ABBV-706, Cisplatin, Budigalimab - Advanced Solid Tumors Phase 1 Active not recruiting 288 2022-12-05 2026-05-07 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 ABBV-927, Budiglimab, modified FOLFIRINOX - Pancreatic Cancer Phase 1 Terminated 40 2021-05-28 2025-01-07 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) Budigalimab, Placebo - Human Immunodeficiency Virus (HIV) Phase 1 Completed 33 2021-03-15 2022-10-17 A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1 ABBV-181, Placebo - Human Immunodeficiency Virus (HIV), HIV Infection Phase 1 Completed 41 2020-01-30 2023-03-09 A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma ABBV-181, ABBV-368, ABBV-927 - Head and Neck Cancer Phase 1 Terminated 3 2020-01-22 2020-12-31 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 ABBV-368, Tilsotolimod, Nab-paclitaxel - Advanced Solid Tumors Cancer Phase 1 Completed 30 2020-01-22 2023-02-27 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 ABBV-927, ABBV-368, ABBV-181 - Cancer, Advanced Solid Tumors Phase 1 Active not recruiting 150 2019-05-21 2026-09-02 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 Livmoniplimab, Budigalimab - Advanced Solid Tumors Cancer Phase 1 Active not recruiting 364 2019-02-21 2025-05-25 A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer ABBV-011, Budigalimab - Small Cell Lung Cancer Phase 1 Completed 132 2018-10-24 2024-02-09 SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers SC-004, ABBV-181 - Cancer Phase 1 Terminated 24 2017-06-14 2019-05-14 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 ABBV-368, ABBV-181 - Advanced Solid Tumors Cancer Phase 1 Completed 139 2017-03-21 2022-04-28
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Conditions studied Neoplasms (15) · Carcinoma, Non-Small-Cell Lung (7) · Carcinoma, Hepatocellular (6) · Squamous Cell Carcinoma of Head and Neck (5) · Small Cell Lung Carcinoma (4) · Triple Negative Breast Neoplasms (4) · Colorectal Neoplasms (3) · Ovarian Neoplasms (3) · Acquired Immunodeficiency Syndrome (2) · Carcinoma, Merkel Cell (2) · Cholangiocarcinoma (2) · Head and Neck Neoplasms (2) · Melanoma (2) · Mesothelioma (2) · Stomach Neoplasms (2)
Sponsors AbbVie (24)
Countries United States (23) · Spain (15) · France (13) · Japan (13) · Puerto Rico (10) · Taiwan (10) · Australia (9) · Israel (9) · Canada (7) · South Korea (7) · Belgium (6) · Germany (6) · Italy (6) · China (4) · Poland (4)
Results publications PMID 32770720 , PMID 34216247 , PMID 34315767 , PMID 34329846 , PMID 35034046 , PMID 35642431 , PMID 39534099 , PMID 41094034 , PMID 41956545 , PMID 42225988
NIH funding 2023 (6) , 2016 (3) , 2019 (3)