Clinical trials /

Telisotuzumab Adizutecan (ABBV-400)

RecruitingPhase 2InterventionalNCT07023289 ↗

This is 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 di

Sponsor
AbbVie
Planned enrollment
140 participants
Start date
September 2, 2025
Primary completion
November 2029 (est.)
Minimum age
18 Years
Interventions
Telisotuzumab Adizutecan, Standard of Care

Official title: 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)

This is a Phase 2 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.

Key Eligibility Criteria

  • Patients with confirmed colon or rectal adenocarcinoma
  • Patients must:
    • have received at least 3 months of platinum-based doublet adjuvant chemotherapy, excluding topoisomerase inhibitors
    • have no radiographic evidence of disease within 6 weeks prior to first study dose
    • have ctDNA positive assay after the end of adjuvant therapy

Treatment

Drug: Telisotuzumab Adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1

ClinicalTrials.gov ID NCT07023289

AbbVie News Center

Where this trial is offered

  • Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621Huntsville, Alabama
    Recruiting
  • Providence Medical Foundation - Fullerton /ID# 274207Fullerton, California
    Recruiting
  • USC Norris Comprehensive Cancer Center /ID# 274550Los Angeles, California
    Recruiting
  • Mayo Clinic Hospital Jacksonville /ID# 274472Jacksonville, Florida
    Recruiting
  • Moffitt Cancer Center /ID# 274372Tampa, Florida
    Recruiting
  • University of Chicago Medical Center /ID# 274742Chicago, Illinois
    Recruiting
  • Johns Hopkins Hospital /ID# 275645Baltimore, Maryland
    Recruiting
  • Massachusetts General Hospital /ID# 273608Boston, Massachusetts
    Recruiting
  • University of Michigan Health System - Ann Arbor /ID# 273511Ann Arbor, Michigan
    Recruiting
  • Scri Minnesota Oncology Hematology, P.A. /ID# 275149Minneapolis, Minnesota
    Recruiting
  • Mayo Clinic-Rochester /ID# 273508Rochester, Minnesota
    Recruiting
  • Northwell Health Center for Advanced Medicine. /ID# 275331Lake Success, New York
    Recruiting
  • Duke University Medical Center /ID# 279457Durham, North Carolina
    Recruiting
  • Northwest Cancer Specialists /ID# 275151Portland, Oregon
    Recruiting
  • Abramson Cancer Center at the University of Pennsylvania /ID# 275407Philadelphia, Pennsylvania
    Recruiting
  • SCRI Oncology Partners /ID# 274522Nashville, Tennessee
    Recruiting
  • Texas Oncology - Central/South Texas /ID# 275154Austin, Texas
    Recruiting
  • The Center For Cancer And Blood Disorders /ID# 278512Fort Worth, Texas
    Recruiting
  • Texas Oncology-Grapevine /ID# 275155Grapevine, Texas
    Recruiting
  • The University of Texas MD Anderson Cancer Center /ID# 273539Houston, Texas
    Recruiting
  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586Fairfax, Virginia
    Recruiting
  • Virginia Cancer Specialists - Fairfax /ID# 274339Fairfax, Virginia
    Recruiting
  • Cliniques Universitaires UCL Saint-Luc /ID# 278669Brussels, Brussels Capital
    Recruiting
  • Universitair Ziekenhuis Leuven /ID# 278668Leuven, Vlaams-Brabant
    Recruiting
  • CHU de Liege /ID# 278857Liège, Belgium
    Recruiting
  • Aarhus Universitetshospital - Skejby /ID# 274498Aarhus, Central Jutland
    Recruiting
  • Odense University Hospital /ID# 274970Odense C, Region Syddanmark
    Recruiting
  • Vejle Sygehus /ID# 274368Vejle, Region Syddanmark
    Recruiting
  • Azienda Ospedaliero Universitaria Careggi /ID# 273604Florence, Firenze
    Recruiting
  • IRCCS Istituto Clinico Humanitas /ID# 273566Rozzano, Lombardy
    Recruiting
  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540Naples, Napoli
    Recruiting
  • Aichi Cancer Center /ID# 275479Nagoya, Aichi-ken
    Recruiting
  • National Cancer Center Hospital East /ID# 273614Kashiwa-shi, Chiba
    Recruiting
  • Kyushu University Hospital /ID# 273710Fukuoka, Fukuoka
    Recruiting
  • Gifu University Hospital /ID# 274179Gifu, Gifu
    Recruiting
  • Yokohama City University Medical Center /ID# 273657Yokohama, Kanagawa
    Recruiting
  • Tohoku University Hospital /ID# 275481Sendai, Miyagi
    Recruiting
  • National Hospital Organization Osaka National Hospital /ID# 274306Osaka, Osaka
    Recruiting
  • Shizuoka Cancer Center /ID# 275480Sunto-gun, Shizuoka
    Recruiting
  • Seoul National University Hospital /ID# 274451Seoul, Seoul Teugbyeolsi
    Recruiting
  • Asan Medical Center /ID# 274454Seoul, Seoul Teugbyeolsi
    Recruiting
  • Samsung Medical Center /ID# 274452Seoul, Seoul Teugbyeolsi
    Recruiting
  • Hospital Universitario Virgen del Rocio /ID# 273720Seville, Sevilla
    Recruiting
  • Hospital Universitario La Paz /ID# 273718Madrid, Spain
    Recruiting
  • Hospital Universitario de Salamanca /ID# 273719Salamanca, Spain
    Recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745Kaohsiung City, Taiwan
    Recruiting
  • China Medical University Hospital /ID# 274644Taichung, Taiwan
    Recruiting
  • National Taiwan University Hospital /ID# 273580Taipei, Taiwan
    Recruiting

Status, sites, and study facts from ClinicalTrials.gov, last posted July 10, 2026 and refreshed here September 5, 2026.View the full record for NCT07023289.