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
NCT ID: NCT07023289
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2025-08-07
2029-11-30
Brief Summary
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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 sites worldwide.
In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telisotuzumab Adizutecan Monotherapy
Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Standard of Care (SOC)
Participants will receive SOC, during the approximately 51 month study duration.
Standard of Care
Standard of care treatment based on investigator's judgement to the active surveillance.
Interventions
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Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Standard of Care
Standard of care treatment based on investigator's judgement to the active surveillance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Providence Medical Foundation /ID# 274207
Fullerton, California, United States
USC Norris Comprehensive Cancer Center /ID# 274550
Los Angeles, California, United States
Johns Hopkins Hospital /ID# 275645
Baltimore, Maryland, United States
Scri Minnesota Oncology Hematology, P.A. /ID# 275149
Minneapolis, Minnesota, United States
Northwell Health Center for Advanced Medicine. /ID# 275331
Lake Success, New York, United States
Northwest Cancer Specialists /ID# 275151
Portland, Oregon, United States
SCRI Oncology Partners /ID# 274522
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas /ID# 275154
Austin, Texas, United States
Texas Oncology-Grapevine /ID# 275155
Grapevine, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 273539
Houston, Texas, United States
Odense University Hospital /ID# 274970
Odense C, Region Syddanmark, Denmark
Vejle Sygehus /ID# 274368
Vejle, Region Syddanmark, Denmark
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540
Naples, Napoli, Italy
Gifu University Hospital /ID# 274179
Gifu, Gifu, Japan
Yokohama City University Medical Center /ID# 273657
Yokohama, Kanagawa, Japan
National Hospital Organization Osaka National Hospital /ID# 274306
Osaka, Osaka, Japan
Shizuoka Cancer Center /ID# 275480
Sunto-gun, Shizuoka, Japan
Seoul National University Hospital /ID# 274451
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 274454
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 274452
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario La Paz /ID# 273718
Madrid, , Spain
Hospital Universitario de Salamanca /ID# 273719
Salamanca, , Spain
National Taiwan University Hospital /ID# 273580
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745
Kaohsiung City, , Taiwan
China Medical University Hospital /ID# 274644
Taichung, , Taiwan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2024-518015-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-534
Identifier Type: -
Identifier Source: org_study_id