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NCT07023289RecruitingPhase 2

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

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)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Jun 2026

Brief summary (registry, in English)

To evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by disease free survival (DFS) by investigator.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (estimated)
First submitted
16 Apr 2025
Start date
24 Sept 2025
Lead sponsor
AbbVie Deutschland GmbH & Co. KG
EU CT number
2024-518015-19-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 24
  • 12 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No availability of surgical tissue sample.
  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

Other

  • Treated or untreated brain or meningeal metastases.

Who the study is looking for

  • Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
  • Surgical tumor material should be available for Signatera™ CtDNA personalized panel design.
  • Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.
  • Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.
  • Circulating tumor deoxyribonucleic acid (ctDNA) positive within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity is confirmed (reported).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumRecruiting
Region Midtjylland
Coordinator of this site? Confirm its status
Aarhus NDenmarkRecruiting
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkRecruiting
Sygehus Lillebaelt - Vejle Sygehus
Coordinator of this site? Confirm its status
VejleDenmarkRecruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario De Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Azienda Ospedaliero-Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.