Featured Trial

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)

Study Identifier
M24-534
CT.gov Identifier
NCT07023289
EudraCT Identifier
Not available
EUCTIS ID
2024-518015-19-00
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

Colorectal cancer refers to cancers that originate in the colon or rectum and ranks as the third most diagnosed cancer in the world. The AndroMETa-CRC-534 Study is evaluating whether a new medication called telisotuzumab adizutecan can help reduce the risk of cancer coming back in people who have a higher chance of recurrence after tumors are removed surgically. This medicine is designed to target a protein called c-Met which is found in colorectal cancer cells and can deliver chemotherapy directly to cancer cells. Please note that telisotuzumab adizutecan is an investigational drug and is not approved by the US and global regulatory authorities. Safety and efficacy have not been established.

In addition to testing this new medication, this study will also be using a new method for detecting cancer cells in the blood called circulating tumor DNA (ctDNA) testing. This is a blood test which can detect cancer even when traditional tests like CT scans and MRIs show no evidence of disease. To do this, a person’s blood sample is compared to a sample of their tumor and blood which is taken at the time of their surgery to determine if there are new cancer cells.

Medical Condition
  • Colorectal Cancer
    • Study Drug
  • Telisotuzumab Adizutecan
  • Standard of Care
    • Phase
    Phase 2
    Estimated Enrollment
    140 patients

    Participating in our Colorectal Cancer Clinical Trials

    If you choose to participate in this study, you will be randomly assigned to one of two groups. The first group will receive the new medication in an IV infusion every three weeks for up to nine months. The second group will undergo active surveillance, which is regular monitoring without receiving the additional treatment. Both you and the study team will know which group you have been sorted into.

    After the initial nine-month treatment or monitoring period, you will continue to be monitored with CT scans every three months for the following two years, and then every six months for the following three years. If your cancer returns at any point, your doctor will recommend the proper standard of care treatment for your colorectal cancer.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    18+ years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be 18 years of age or older
    • Have been diagnosed with colorectal cancer, had tumor resected, and received at least 3 months of chemotherapy
    • Have no sign of tumor on CT/MRI scans, but have tumor cells present in their bloodstream (ctDNA positive)

    Participants must not:

    •   Have no tumor sample available
    •   Have a history of significant lung disease
    • Have metastases in the brain, either treated or untreated

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 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.

    Study Locations

    Location
    Status
    Location
    Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621
    Huntsville, Alabama, United States, 35805
    Status
    Recruiting
    Location
    Providence Medical Foundation - Fullerton /ID# 274207
    Fullerton, California, United States, 92835-3826
    Status
    Recruiting
    Location
    USC Norris Comprehensive Cancer Center /ID# 274550
    Los Angeles, California, United States, 90033
    Status
    Recruiting
    Location
    Mayo Clinic Hospital Jacksonville /ID# 274472
    Jacksonville, Florida, United States, 32224
    Status
    Recruiting
    Location
    Moffitt Cancer Center /ID# 274372
    Tampa, Florida, United States, 33612
    Status
    Recruiting
    Location
    University of Chicago Medical Center /ID# 274742
    Chicago, Illinois, United States, 60637
    Status
    Recruiting
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