Home › Trials › NCT07023289

Comparing IV telisotuzumab adizutecan versus standard care for colorectal cancer patients who are ctDNA-positive with no visible 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)

Phase 2 Interventional AbbVie · NCT07023289

This tests whether an IV drug, telisotuzumab adizutecan, or standard care can help adults with colorectal cancer who are ctDNA-positive after adjuvant therapy but have no visible disease on scans.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, radiation, telisotuzumab
Locations41 sites (Huntsville, Alabama and 40 other locations)
Trial IDNCT07023289 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2 interventional trial enrolls about 140 adults with resected colorectal adenocarcinoma who are ctDNA-positive after finishing adjuvant platinum-based chemotherapy and have no radiographic evidence of disease. Participants are assigned to one of two arms: intravenous telisotuzumab adizutecan alone or standard of care alone, with tumor tissue submitted for biomarker (c-Met) testing and personalized ctDNA panel confirmation. The study monitors safety (adverse events) and change in disease activity over a planned duration of roughly 51 months, with regular on-site visits for infusions and follow-up imaging and blood tests. The protocol includes requirements for available surgical tumor material and timely start of treatment after ctDNA confirmation.

Who should consider this trial

Good fit: Adults with histologically confirmed colon or rectal adenocarcinoma who completed at least three months of platinum-based doublet adjuvant chemotherapy, have no radiographic evidence of disease, are ctDNA-positive after adjuvant therapy, and can provide surgical tumor material for testing are ideal candidates.

Not a fit: Patients with visible radiographic disease, who are ctDNA-negative after adjuvant therapy, who did not receive the required adjuvant chemotherapy regimen, or who cannot provide tumor tissue are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce cancer recurrence in patients with molecular evidence of residual disease and provide a targeted adjuvant option for ctDNA-positive colorectal cancer.

How similar studies have performed: ctDNA-directed adjuvant strategies are an active and promising area of research with early signals of benefit, but telisotuzumab adizutecan itself is investigational in this setting and not yet proven effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
* Surgical tumor material should be available and must be submitted for Signatera personalized panel and assessment of c-Met protein levels.
* Must have received at least 3 months of platinum-based doublet adjuvant 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 after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA 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.
* For participants with oligometastatic disease a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet therapy must have been administered.

Exclusion Criteria:

* 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.

Where this trial is running

Huntsville, Alabama and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal CancerTelisotuzumab AdizutecanABBV-400, Stand of CareCancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.