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Telisotuzumab Adizutecan for Colorectal Cancer After Adjuvant Therapy

This study is looking at an investigational drug called Telisotuzumab Adizutecan for adults with colorectal cancer (CRC) who have completed initial treatment and have circulating tumor DNA (ctDNA) but no visible disease. The study aims to see if Telisotuzumab Adizutecan alone changes disease activity compared to standard of care (SOC) alone. You would either receive Telisotuzumab Adizutecan through an IV (into a vein) or receive SOC, which is chosen by your doctor. The study plans to enroll about 140 participants worldwide and will measure how long people live without their disease returning. The current status of this study is unclear.

Study design
This interventional study plans to enroll about 140 adult participants and compares Telisotuzumab Adizutecan alone to standard of care alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease-free survival events for up to approximately 51 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07023289

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~140 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Telisotuzumab AdizutecanStandard of Care

At a glance

Recruiting sites
48 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with disease free survival (DFS) Event
Measured over Up to Approximately 51 Months

Conditions

Colorectal Cancer

Explore related trials

Colorectal CarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

48 sites across 35 states
Texas4
Seoul Teugbyeolsi3
Taiwan3
California2
Florida2
Minnesota2
Virginia2
Region Syddanmark2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).
For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy.

Exclusion

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.

What this trial measures

  • Percentage of Participants with disease free survival (DFS) EventUp to Approximately 51 Months

    DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.