Telisotuzumab Adizutecan
Sponsors
AbbVie Deutschland GmbH & Co. KG, AbbVie
Conditions
Colorectal CancerEsophageal AdenocarcinomaGastric/Esophageal CancerGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaHigh-Grade Serous Ovarian CancerLocally Advanced Unresectable or Metastatic Gastric AdenocarcinomaMetastatic Colorectal Cancer
Phase 1
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
RecruitingNCT05005403
Start: 2021-11-01End: 2027-07-01Target: 694Updated: 2026-04-03
Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer
RecruitingNCT06464692
Start: 2024-09-30End: 2028-09-30Target: 30Updated: 2025-05-22
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
RecruitingNCT06772623
Start: 2025-03-06End: 2027-11-01Target: 252Updated: 2026-02-27
Phase 2
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
RecruitingNCT06628310
Start: 2024-12-13End: 2030-10-01Target: 180Updated: 2026-03-30
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
RecruitingNCT06820463
Start: 2025-04-24End: 2028-04-01Target: 390Updated: 2026-04-03
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
RecruitingNCT07005102
Start: 2025-08-03End: 2031-12-01Target: 854Updated: 2026-04-03
A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
RecruitingNCT07023289
Start: 2025-08-07End: 2029-11-01Target: 140Updated: 2026-03-13
A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Subjects with Metastatic Colorectal Cancer (AndroMETa-CRC-533)
RecruitingCTIS2024-512981-33-00
Start: 2025-07-09Target: 104Updated: 2025-11-25
A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects with Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)
RecruitingCTIS2024-518015-19-00
Start: 2025-09-24Target: 24Updated: 2026-01-14
A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with Osimertinib as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
RecruitingCTIS2024-518586-10-00
Start: 2025-09-18Target: 44Updated: 2025-11-24
A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
RecruitingNCT07155187
Start: 2025-12-10End: 2030-09-01Target: 430Updated: 2026-03-11
A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan
RecruitingNCT07196644
Start: 2025-10-29End: 2030-12-01Target: 125Updated: 2026-03-11
Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
Not yet recruitingCTIS2025-521124-29-00
Target: 25Updated: 2026-02-10
A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma
Not yet recruitingNCT07490301
Start: 2026-06-03End: 2031-06-01Target: 900Updated: 2026-03-24
Phase 3
A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
RecruitingNCT06614192
Start: 2024-11-08End: 2028-10-31Target: 460Updated: 2025-08-26
AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff
Not yet recruitingCTIS2024-512804-20-00
Target: 87Updated: 2025-12-10