Telisotuzumab Adizutecan

Phase 3Small molecule

AbbVie

Telisotuzumab Adizutecan is one of 183 small molecule programs targeting Colorectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

182

Competitors

Pipeline

Status by Indication[3][1]

Indication

Colorectal CancerRecruiting

Non-Small Cell Lung CancerRecruiting

Metastatic Pancreatic Ductal AdenocarcinomaRecruiting

Solid Tumors Harboring MET AmplificationRecruiting

Metastatic Gastric AdenocarcinomaActive, not recruiting

Head and Neck Squamous Cell CarcinomaNot yet recruiting

CancersNot yet recruiting

Metastatic Colorectal CancerRecruiting

Colorectal CancerPhase 3

Recruiting

Non-Small Cell Lung CancerPhase 1

Recruiting

Metastatic Pancreatic Ductal AdenocarcinomaPreclinical

Recruiting

Solid Tumors Harboring MET AmplificationPhase 2

Recruiting

Metastatic Gastric AdenocarcinomaPhase 2

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Not yet recruiting

CancersPhase 2

Not yet recruiting

Metastatic Colorectal CancerPhase 3

Recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

SKB264

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Phase 3

5 2

Telisotuzumab Adizutecan

AbbVie

Phase 3

4 3

KN046

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

Phase 3

4 4

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Phase 3

3 5

Remeron

OOrganon and Co

Preclinical

1 6

Treatment

GSK

Preclinical

1 7

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—10

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1Recruiting

Non-Small Cell Lung Cancer

NCT05005403

Q4 2027

PreclinicalRecruiting

Non-Small Cell Lung Cancer

NCT06772623

Q2 2028

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT06820463

Q3 2028

Phase 1/2Recruiting

Metastatic Colorectal Cancer

NCT06464692

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, 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

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT07155187·490 enrolled

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT06772623·252 enrolled

A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

Recruiting· AbbVie logo

AbbVie·Phase 1·NCT05005403·694 enrolled

Show 1 more trial

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

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT07005102·854 enrolled

Metastatic Colorectal Cancer3 trials

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

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06614192·460 enrolled

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

Recruiting· AbbVie logo

AbbVie·Phase 1/2·NCT06464692·30 enrolled

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

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT06820463·390 enrolled

Colorectal Cancer2 trials

An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT07525206·990 enrolled

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)

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT07023289·140 enrolled

ESS1 trial

Expanded Access to Telisotuzumab Adizutecan

Available· AbbVie logo

AbbVie··NCT05982873

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Phase 3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Not yet recruiting· AbbVie logo

AbbVie·Phase 3·NCT07821684·660 enrolled

5 more indications

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination With FOLFOX Compared to Standard of Care in Subjects With First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288

Recruiting· AbbVie logo

AbbVie·Preclinical·NCT07490301·900 enrolled

Cancers1 trial

A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)

Not yet recruiting· AbbVie logo

AbbVie·Phase 2·NCT07769502·168 enrolled

Solid Tumors Harboring MET Amplification1 trial

A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT07196644·100 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Phase 2 Open-Label Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Pembrolizumab as First-Line Treatment in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting· AbbVie logo

AbbVie·Phase 2·NCT07744126·150 enrolled

Metastatic Gastric Adenocarcinoma1 trial

A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT06628310·185 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Telisotuzumab Adizutecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Telisotuzumab Adizutecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Telisotuzumab Adizutecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AbbVie

Telisotuzumab Adizutecan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q2 2028

Q3 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Metastatic Colorectal Cancer3 trials

Colorectal Cancer2 trials

ESS1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Cancers1 trial

Solid Tumors Harboring MET Amplification1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Metastatic Gastric Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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