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

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45

Trial Details

NCT ID
NCT07023289
Phase
PHASE2
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Telisotuzumab Adizutecan
  • Standard of Care
Locations (sample)
  • Huntsville, Alabama, United States|34.7304,-86.58594
  • Fullerton, California, United States|33.87029,-117.92534
  • Los Angeles, California, United States|34.05223,-118.24368
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility 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…
  • Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycl…

For full eligibility, visit ClinicalTrials.gov.

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