Telisotuzumab adizutecan

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

AbbVie Inc. ABBV · c-MET; Colorectal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma; Non-Small Cell Lung Cancer; Non-Squamous Non-Small Cell Lung Cancer

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    4

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indications
c-MET; Colorectal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma; Non-Small Cell Lung Cancer; Non-Squamous Non-Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 CompletedFirst trial start 3 Aug 20253 linked trials
  4. Phase 3 Current stageFirst trial start 3 Aug 20254 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Telisotuzumab adizutecan. Editors add each one with its source.

Filed application

No filed application is on record for Telisotuzumab adizutecan. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Telisotuzumab adizutecan.

Clinical trials

Trials linked to Telisotuzumab adizutecan
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07525206ClinicalTrials.gov record for NCT07525206 (opens in a new tab)AndroMETa-CRCA Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal CancerPhase 3Recruiting990 (estimated)May 2029 (estimated) No

Publications listing AndroMETa-CRC (1), newest first

  1. A randomized Phase 1 study of telisotuzumab adizutecan (ABBV-400, Temab-A) in combination with bevacizumab versus trifluridine-tipiracil with bevacizumab in patients with metastatic colorectal cancer.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2026 Oct 24

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT07490301ClinicalTrials.gov record for NCT07490301 (opens in a new tab)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 AdenocarcinomaPhase 2/3Recruiting900 (estimated)Jun 2031 (estimated) No
NCT07155187ClinicalTrials.gov record for NCT07155187 (opens in a new tab)A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung CancerPhase 2/3Recruiting490 (estimated)Sep 2030 (estimated) No
NCT07005102ClinicalTrials.gov record for NCT07005102 (opens in a new tab)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 CancerPhase 2/3Recruiting854 (estimated)Nov 2036 (estimated) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

No FDA approvals on record for this drug.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Telisotuzumab adizutecan.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.