Telisotuzumab Adizutecan

Phase 2Small molecule

Telisotuzumab Adizutecan is one of 93 small molecule programs targeting Metastatic Colorectal Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Colorectal CancerActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Solid Tumors Harboring MET AmplificationRecruiting

Metastatic Gastric AdenocarcinomaActive, not recruiting

Locally Advanced or Metastatic Non-Squamous NSCLCNot yet recruiting

Metastatic Pancreatic Ductal AdenocarcinomaRecruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Recruiting

Solid Tumors Harboring MET AmplificationPhase 2

Recruiting

Metastatic Gastric AdenocarcinomaPhase 2

Active, not recruiting

Locally Advanced or Metastatic Non-Squamous NSCLCPhase 2

Not yet recruiting

Metastatic Pancreatic Ductal AdenocarcinomaPreclinical

Recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Conmana

BBetta Pharmaceuticals Co., Ltd.

Phase 3

14 2

Savolitinib

AstraZeneca

Phase 3

4 3

HLX43

Shanghai Henlius Biotech

Phase 3

3 4

Telisotuzumab Adizutecan

AbbVie

Phase 2

3 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

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

Treatment

1 10

PD-1 Inhibitors

BBioNTech US 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

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT06614192

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

Phase 2Recruiting

Cancers

NCT07769502

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer3 trials

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

AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT06614192·74 enrolled

Non-Small Cell Lung Cancer3 trials

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 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

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

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

Non-Squamous Non-Small Cell Lung Cancer2 trials

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

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

ESS1 trial

Expanded Access to Telisotuzumab Adizutecan

Available· AbbVie logo

AbbVie··NCT05982873

7 more indications

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

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT07744126·150 enrolled

Unresectable Colorectal Cancer1 trial

A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan With or Without Chemotherapy as a First-Line or Second-Line Therapy for Unresectable Colorectal Cancer

Not yet recruiting·RRemeGen Co., Ltd.·Phase 2·NCT07895355·412 enrolled

Locally Advanced or Metastatic Non-squamous NSCLC1 trial

Phase II Clinical Study to Evaluate the Efficacy and Safety of Telisotuzumab Adizutecan in Combination With RC148 as First-Line Therapy for Non-Squamous Non-Small-Cell Lung Cancer

Not yet recruiting·RRemeGen Co., Ltd.·Phase 2·NCT07874282·200 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)

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT07769502·168 enrolled

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

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

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 — 18 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 2[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]

Metastatic Colorectal Cancer3 trials

Non-Small Cell Lung Cancer3 trials

Colorectal Cancer2 trials

Non-Squamous Non-Small Cell Lung Cancer2 trials

ESS1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Unresectable Colorectal Cancer1 trial

Locally Advanced or Metastatic Non-squamous NSCLC1 trial

Cancers1 trial

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Solid Tumors Harboring MET Amplification1 trial

Metastatic Gastric Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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