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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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment140 people
  • Recruiting US sites21
  • SponsorAbbVie
  • RegistryNCT07023289

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

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 one-minute explainerNCT070232891 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

telisotuzumab adizutecan. An antibody-drug conjugate (ADC) composed of a monoclonal antibody against the tumor-associated antigen (TAA) proto-oncogene c-Met (hepatocyte growth factor receptor; HGFR) linked to an undisclosed topoisomerase inhibitor, with potential antineoplastic activity. Upon intravenous administration of anti-c-Met ADC ABBV-400, the monoclonal antibody moiety targets and binds to c-Met expressed on tumor cells. Upon binding and internalization, the topoisomerase inhibitor is released, which binds to and inhibits topoisomerase, thereby inhibiting DNA replication and killing the c-Met-expressing cancer cells. c-Met, a receptor tyrosine kinase overexpressed or mutated in many tumor cell types, plays key roles in tumor cell proliferation, survival, invasion, metastasis and tumor angiogenesis. NCI Drug Dictionary

Treatments listed in the registry

  • Telisotuzumab Adizutecan (Drug): Intravenous (IV) Infusion
  • Standard of Care (Drug): Standard of care treatment based on investigator's judgement to the active surveillance.

The study

Treatment groups

Non Randomized · Parallel · masking: None

Telisotuzumab Adizutecan Monotherapy (Experimental)

Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.

Standard of Care (SOC) (Active Comparator)

Participants will receive SOC, during the approximately 51 month study duration.

Goals

What the study measures

Main goals

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

Other goals

  • Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
  • Overall Survival (OS)

Planned enrollment: 140 (estimated).

Where

Recruiting US sites

  • Providence Medical Foundation - Fullerton /ID# 274207, Fullerton, California
  • USC Norris Comprehensive Cancer Center /ID# 274550, Los Angeles, California
  • Mayo Clinic Hospital Jacksonville /ID# 274472, Jacksonville, Florida
  • Moffitt Cancer Center /ID# 274372, Tampa, Florida
  • University of Chicago Medical Center /ID# 274742, Chicago, Illinois
  • Johns Hopkins Hospital /ID# 275645, Baltimore, Maryland
  • Massachusetts General Hospital /ID# 273608, Boston, Massachusetts
  • University of Michigan Health System - Ann Arbor /ID# 273511, Ann Arbor, Michigan
  • Scri Minnesota Oncology Hematology, P.A. /ID# 275149, Minneapolis, Minnesota
  • Mayo Clinic-Rochester /ID# 273508, Rochester, Minnesota
  • Northwell Health Center for Advanced Medicine. /ID# 275331, Lake Success, New York
  • Duke University Medical Center /ID# 279457, Durham, North Carolina
  • Northwest Cancer Specialists /ID# 275151, Portland, Oregon
  • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275407, Philadelphia, Pennsylvania
  • SCRI Oncology Partners /ID# 274522, Nashville, Tennessee
  • Texas Oncology - Central/South Texas /ID# 275154, Austin, Texas
  • The Center For Cancer And Blood Disorders /ID# 278512, Fort Worth, Texas
  • Texas Oncology-Grapevine /ID# 275155, Grapevine, Texas
  • The University of Texas MD Anderson Cancer Center /ID# 273539, Houston, Texas
  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586, Fairfax, Virginia
  • Virginia Cancer Specialists - Fairfax /ID# 274339, Fairfax, Virginia

26 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 8, 2026. Public record; not medical advice.

For you, or someone you love

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